A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors
Latest Information Update: 09 Dec 2022
At a glance
- Drugs Baricitinib (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Acronyms RA-BEACON
- Sponsors Eli Lilly and Company; Lilly Korea
- 07 Dec 2022 Results from NCT01710358 and NCT01721044 assessing the relative impact of pain and disease activity on improvements in fatigue, published in the JCR: Journal of Clinical Rheumatology
- 09 Nov 2021 Results assessing effects of Baricitinib on fatigue that are influenced by disease activity and those that are independent of disease activity in patients from the RA-BEAM and RA-BEACON trials, presented at the ACR Convergence 2021
- 09 Nov 2021 Results of post-hoc analysis of 3 studies (RA-BEGIN (NCT01711359); RA-BEAM (NCT01710358) & RA-BEACON (NCT01721044)) assessing the relative importance of PROs on the Patient Global Assessment of Disease Activity (PtGA) and health-related quality of life (HRQoL) and whether these differ in patients with good disease control compared with those not in low disease activity (LDA) or remission in different patient populations, presented at the ACR Convergence 2021.
Most Recent Events
Trial Overview
Outcome
Purpose
This trial investigated the efficacy and tolerability of baricitinib [LY 3009104, INCB 028050] in patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to tumour necrosis factor (TNF) inhibitors, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).
Comments
According to an Eli Lilly media release, U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies.
According to an Eli Lilly media release, the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib (oral, once-daily) for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. For the 4-mg dose, the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, however it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
Baricitinib (2mg and 4mg oral tablet) is approved in Japan and Europe for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate.
Primary Endpoints
Proportion of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
[ Time Frame: Week 12 ] [1]
Other Endpoints
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
description: The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. time_frame: Baseline, Week 12
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
description: DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. time_frame: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
description: The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity. time_frame: Week 12
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders. time_frame: Week 12
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
description: The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. time_frame: Baseline, Week 12
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
description: DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. time_frame: Baseline, Week 12
Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
description: The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity. time_frame: Week 12
Percentage of Participants Achieving ACR20 Response
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders. time_frame: Week 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
description: ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders. time_frame: Week 12 and Week 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
description: ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders. time_frame: Week 12 and Week 24
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
description: DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. time_frame: Baseline, Week 12
Change From Baseline in Clinical Disease Activity Index Score
description: The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. time_frame: Baseline, Week 24
Change From Baseline in Measures of SDAI Score
description: The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement. time_frame: Baseline, Week 24
Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
description: The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1. time_frame: Week 24
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
description: Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition. time_frame: Baseline, Week 24
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
description: A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10. time_frame: Baseline, Week 24
Change From Baseline in Worst Joint Pain NRS
description: Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10. time_frame: Baseline, Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
description: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue. time_frame: Baseline, Week 12, Week 24
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
description: The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status. time_frame: Baseline, Week 12, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
description: European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. time_frame: Baseline, Week 12, Week 24
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
description: The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes. time_frame: Baseline, Week 12, Week 24
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
time_frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
time_frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose. [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Rheumatoid arthritis | treatment | active-disease, moderate, severe |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT01721044 | C-reactive protein (CRP) | Eligibility Criteria, Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 525
Actual: 527
- Sex male & female
- Age Group ≥ 18 years; adult
Patient Inclusion Criteria
1] are at least 18 years of age
2] have a diagnosis of adult-onset RA as defined by the ACR(American College of Rheumatology)/EULAR (European League Against Rheumatism) 2010 Criteria for the Classification of RA (Rhumatoid Arthritis) (Aletaha et al. 2010)
3] have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
a. If significant surgical treatment of a joint has been performed, that joint cannot be counted in the TJC (tender joint count)or SJC (swollen joint count)for entry or enrollment purposes.
4] have a C-reactive protein (or hsCRP) measurement =1 times the upper limit of normal (ULN) based on the most recent data (if available)
5] have been treated at approved doses with at least 1 biologic TNF-a inhibitor (eg, infliximab, certolizumab, golimumab, etanercept, adalimumab) for at least 3 months and in the opinion of the investigator either:
a. experienced insufficient efficacy or loss of efficacy at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response or
b. experienced intolerance of such treatment (3 months treatment with TNF-a inhibitor not required in case of intolerance).
6] have had regular use of at least 1 cDMARD for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response, as specified below:
a. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.
b. For patients entering the trial on MTX doses <15 mg/week, there must be clear documentation in the medical record that higher doses of MTX were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines.
c. Local standard of care should be followed for concomitant administration of folic acid.
d. For patients entering the trial while receiving the following DMARDs, the dose must be stable for at least 8 weeks prior to study entry and not exceed the dose listed: hydroxychloroquine up to 400 mg/day; sulfasalazine up to 3000 mg/day; leflunomide (Arava®, Sanofi-Aventis) up to 20 mg/day; and azathioprine up to 150 mg/day or 2 mg/kg/day.
i. Any recently discontinued cDMARD must not have been taken within 4 weeks prior to study entry.
7] are able to read, understand, and give written informed consent
Patient Exclusion Criteria
- Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization - Are currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization - Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization - Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs - Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study - Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization - Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study - Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants with secondary Sjogren's syndrome are not excluded.) - Have a diagnosis of Felty's syndrome - Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant - Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure - Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data - Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair - Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2) - Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN - Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years - Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination) - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection - Have had symptomatic herpes zoster infection within 12 weeks prior to study entry - Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia) - Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study - Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) - Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study - Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g. Fridericia's corrected QT interval >500 millisecond [msec]) - Have symptomatic herpes simplex at the time of study enrollment - Have evidence of active or latent tuberculosis (TB)
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| KCT0001004 | Clinical Research Information Service (CriS) - Republic of Korea |
| NCT01721044 | ClinicalTrials.gov: US National Institutes of Health |
| CCRN885 | Comprehensive Clinical Research Network |
| 14058 | Eli Lilly |
| I4V-MC-JADW | Eli Lilly Secondary Identifier |
| EudraCT2012-002323-15 | European Clinical Trials Database |
| JapicCTI132156 | Japan Pharmaceutical Information Center - Clinical Trials Information |
| 13606 | United Kingdom Clinical Research Network |
Organisations
- Sponsors Eli Lilly and Company; Lilly Korea
- Affiliations Eli Lilly and Company; Incyte Corporation; Lilly Korea
Trial Dates
-
Initiation Dates
Planned : 01 Jan 2013
Actual : 25 Jan 2013
-
Primary Completion Dates
Actual : 01 Jun 2014
-
End Dates
Planned : 01 Sep 2014
Actual : 01 Sep 2014
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Argentina; Australia; Austria; Belgium; Canada; Denmark; England; France; Germany; Greece; Israel; Italy; Japan; Mexico; Netherlands; Poland; Puerto Rico; South Korea; Spain; Switzerland; Turkey; USA
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| BaricitinibPrimary Drug | Oral | Tablet |
Placebo
Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24. Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study. Drug: Placebo (Administered orally) Drug: cDMARD (Participants will continue to take background cDMARD therapy throughout study.)
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Drug: Baricitinib (Administered orally) Other Name: LY 3009104, INCB 028050 Drug: cDMARD (Participants will continue to take background cDMARD therapy throughout study.)
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Drug: Baricitinib (Administered orally) Other Name: LY 3009104, INCB 028050 Drug: cDMARD (Participants will continue to take background cDMARD therapy throughout study.)
Results
Therapeutic efficacy
Pooled data from the study showed that baricitinib maintained efficacy and normative physical function bDMARD-IR population up to 6.9 yrs (360 weeks). Patients in baricitinib 4 and 2 mg arms had higher LDA and (remission) REM RR vs PBO at LTE entry (week 24). PBO-treated patients achieved comparable RR to patients in the BARICITINIB 4 mg arm by week 48 (24 weeks after switch to baricitinib 4 mg) and up to week 360. Of patients enrolled to RA-BEYOND, approx. 50% in baricitinib 4 mg, 65% in 2 mg and 61% in PBO remained active at week 156; 17%, 26% and 26% at week 360, respectively. SDAI LDA RR were 47%/70% and 61%/74% for patients treated with baricitinib 4 mg and 2 mg, at week 156 (year 3)/ 360 (year 6.9), respectively; SDAI REM RR were 15%/26% and 26%/26% for baricitinib 4 mg and 2 mg, at week 156/360, respectively (Table 1). SDAI and CDAI had comparable RR. DAS-28CRP LDA RR were similar to SDAI and CDAI, while REM RR were about twice those of SDAI and CDAI. HAQ-DI ≤ 0.5 RR was 15%/26% (baricitinib 4 mg), 21%/15% (baricitinib 2mg), and 9%/3% (PBO) at 3/6.9 yrs.
Results from a phase III long-term extension study showed that that 4 mg once daily was the most efficacious dose of baricitinib for patients with rheumatoid arthritis (RA); increases in disease activity were consistently seen with dose reduction from 4 mg to 2 mg in well-controlled patients. Among patients who achieved sustained disease control with baricitinib 4 mg, dose reduction to 2 mg resulted in significant increases in disease activity at 12, 24, and 48 weeks; however, the majority of patients in both groups maintained the state of low-dose activity (LDA) or remission. Rescue rates were 7.3% for baricitinib 4 mg, 17.1% for baricitinib 2 mg. Most rescued patients could regain LDA or remission [3] .
The randomised, double-blind phase III RA-BEACON trial of baricitinib in patients with rheumatoid arthritis (RA) met its primary endpoint of improved ACR20 response at 12 weeks, compared to placebo. Updated results from phase III trial showed that the baricitinib 2mg treated patients was classified into three groups based on their CDAI trajectory patterns, group 1 (n = 90, 52%), group 2 (n =29, 17%), and group 3 (n = 55, 32%). Group 1 had lower baseline CDAI (34), achieved 53% improvement in group mean of CDAI at week 4 and 64% improvement at week 12, maintained similar improvement till week 24. Group 2 had higher CDAI at baseline (51), 32% improvement in group mean of CDAI at week 4 and higher improvement at week 12 (52%) and week 24 (66%). Group 3 had similar baseline CDAI values (48) to Group 2 but smaller improvement in CDAI and 18% at week 24. The majority of patients had no radiographic progression with the highest proportion in Group 1. The trajectories of average pain VAS, Health Assessment Questionnaire–Disability Index (HAQ-DI), tender joint count, and swollen joint count showed a trajectory similar to corresponding 3 groups were consistent in all three groups. As compared to group 1 and 2, group 3 had more pain, worse physical function and large proportion of patients at baseline [4] . At week 12, ACR20 response rates were 53%, 49% and 32% for 4mg, 2mg and placebo, respectively (p ≤ 0.001) and were 45%, 39% and 21% for 4mg, 2mg and placebo, respectively (p ≤ 0.001), at week 24. Improvement in physical component score of SF-36 was statistically significant in patients treated with baricitinib compared with placebo at week 4, which was sustained through week 24. Baricitinib also significantly improved fatigue and reduced the duration of morning joint stiffness, as early as week 4, compared with placebo; this effect was maintained throughout the study. There were also significant improvements in physical functioning and pain in the baricitinib-treated groups at week 12 and week 24, compared with placebo. A significantly greater proportion of patients treated with baricitinib also achieved a DAS28-CRP score below 2.6 and HAQ-DI of 0.3 at week 12. Significant improvements in ACR response rates, DAS28-CRP and HAQ-DI with baricitinib compared with placebo at week 12 were maintained through week 24. The trial enrolled 527 patients with moderate to severe RA who had an inadequate response to a TNF inhibitor, despite ongoing treatment with conventional DMARDs. Baricitinib was dosed at 2mg or 4mg daily for 6 months [5] [6] [1] .
Top-line results showed that the primary endpoint (improved proportion of patients meeting the American College of Rheumatology 20% improvement [ACR20] response compared to placebo, after 12 weeks' treatment) was met in patients with moderately-to-severely active rheumatoid arthritis who received baricitinib. All patients were also receiving stable doses of conventional disease-modifying antirheumatic drugs. [1]
Adverse events
Treatment with baricitinib in a phase III RA-BEACON trial was observed to be safe and well tolerated in patients with rheumatoid arthritis (RA) up to 8.4 years. The rate of treatment-emergent adverse events was higher for baricitinib 4mg (77%) and baricitinib 2mg (71%) than for placebo (64%). The incidence of serious adverse events were 10% in 4mg arm, 4% in 2mg arm of baricitinib and 7% for placebo. One death was reported due to stroke in the baricitinib 4mg arm. There were no cases of opportunistic infections, tuberculosis or gastrointestinal perforations. The most commonly reported adverse events in patients on baricitinib were headache, upper respiratory tract infection and nasopharyngitis. The trial enrolled 527 patients with moderate to severe RA who had an inadequate response to a TNF inhibitor, despite ongoing treatment with conventional DMARDs. Baricitinib was dosed at 2mg or 4mg daily for 6 months [5] [6] [1] .
Top-line results showed that the incidence of treatment-emergent adverse events was higher in patients with rheumatoid arthritis who received baricitinib than in placebo recipients. The most frequently reported adverse events in baricitinib recipients were headache, upper respiratory tract infection and nasopharyngitis. Discontinuation rates due to adverse events, and the incidence of serious adverse events, were similar in baricitinib and placebo recipients. [1]
Publications
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Eli Lilly. Lilly and Incyte Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib in Moderate to Severe Rheumatoid Arthritis. Media-Rel 2014;.
Media Release -
Takeuchi T, Genovese M, Haraoui B, Xie L, Klar R, Correia ALP, et al. Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study. EULAR-2017 2017; abstr. SAT0072.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=344719 -
Genovese M, Weinblatt M, Wu J, Jia B, Quebe A, Sun L, et al. Patient Disease Trajectories in Baricitinib- 2 Mg- Treated Patients with Rheumatoid Arthritis and Inadequate Response to Biologic DMARDs . ACR/ARHP-2019 2019; abstr. 1350.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Eli Lilly. New data from pivotal RA-BEACON study show significant improvement in patient-reported outcomes in rheumatoid arthritis patients treated with baricitinib compared to placebo. Media-Rel 2016;.
Media Release -
Eli Lilly, Incyte Corporation. Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics. Media-Rel 2016;.
Media Release -
Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N-Engl-J-Med 2016;374(13):1243-52.
PubMed | CrossRef Fulltext -
Taylor P, Zhu B, Gaich C, Zhang X, DeLozier AM, Schlichting D, et al. Baricitinib Showed Rapid and Greater Reduction in Pain Compared to Adalimumab or Placebo in Patients with Rheumatoid Arthritis. EULAR-2017 2017; abstr. SAT0055.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=349500 -
I COBII, Gaich C, DeLozier AM, Quebe A, Sun L, Otawa S, et al. Converting Patient-Reported Physical Function Outcomes Scores to Promis Metric Scores in Phase 3 Trials of Baricitinib in Rheumatoid Arthritis. EULAR-2018 2018; abstr. FRI0013.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=397062 -
Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, et al. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology 2018;.
PubMed | CrossRef Fulltext -
I CBII, Jia B, Wu J, Quebe A, Kannowski C, Otawa S, et al. Baricitinib 2-mg Provides Greater Improvements in Patient-Reported Outcomes Across All Disease Activity Levels Compared to Placebo: Post-hoc Analyses of RA-BEACON and RA-BUILD Trials. ACR/ARP-2020 2020; abstr. 1228.
Available from: URL: https://acrabstracts.org/abstract/ -
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, et al. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann-Rheum-Dis 2018;.
PubMed | CrossRef Fulltext -
Smolen J, Genovese M, Takeuchi T, Hyslop D, Macias WL, Rooney TP, et al. Safety Profile of Baricitinib in Patients with Active Ra: an Integrated Analysis. EULAR-2016 2016; abstr. THU0166.
Available from: URL: http://www.abstracts2view.com/eular/view.php?nu=EULAR16L_THU0166 -
Takeuchi T, Genovese MC, Haraoui B, Li Z, Xie L, Klar R, et al. Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study. EULAR-2018 2018; abstr. SAT0253.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=397061 -
Pope J, Lee Y, Curtis Jr, Mo D, Rooney T, Xie L, et al. Baricitinib 4 Mg and 2 Mg Once Daily Reduced Pain in Both Patients Who Were Opioid Users and Non- users in Active Rheumatoid Arthritis: A Post- hoc Analysis of Phase 3 Trials . ACR/ARHP-2019 2019; abstr. 1880.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Chen Y-H, Chen Y-M, Smolen JS, Takeuchi T, Muller R, Walker D, et al. Incidence Rate and Characterization of Herpes Zoster in Patients with Moderate-to-Severe Rheumatoid Arthritis: an Update from Baricitinib Clinical Studies. EULAR-2019 2019; abstr. FRI0164.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/index.cfm?c=a&view=2&item=2019FRI0164 -
Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib, an Oral Janus Kinase (Jak)1/Jak2 Inhibitor, in Patients with Active Rheumatoid Arthritis (Ra) and an Inadequate Response to Tnf Inhibitors: Results of the Phase 3 Ra-Beacon Study. EULAR-2015 2015; abstr. OP0029.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=246874 -
Fautrel B, Jia B, Wu J, Ji J, Birt J, Haladyj E, et al. Treatment Effect of Baricitinib on Fatigue: Mediation Analysis Results from Two Phase 3 Trials. ACR/ARP-2021 2021; abstr. 1235.
Available from: URL: https://acrabstracts.org/abstract/treatment-effect-of-baricitinib-on-fatigue-mediation-analysis-results-from-two-phase-3-trials/ -
Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, et al. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J-Rheumatol 2018;.
PubMed | CrossRef Fulltext -
Wells A, Griffing K, Quebe A, Sun L, Zhang H, Reis P. Benefit and Risk Profiles of Janus Kinase Inhibitors Approved in the US for the Treatment of RA. ACR/ARP-2020 2020; abstr. 1762.
Available from: URL: https://acrabstracts.org/abstract/benefit-and-risk-profiles-of-janus-kinase-inhibitors-approved-in-the-us-for-the-treatment-of-ra/ -
Emery P, Tanaka Y, Cardillo TE, Schlichting DE, Beattie S, Chen L, et al. Temporary Interruptions of Study Drug During the Baricitinib Phase 3 Rheumatoid Arthritis Program. EULAR-2017 2017; abstr. FRI0124.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=349216 -
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann-Rheum-Dis 2021;.
PubMed | CrossRef Fulltext -
Emery P, McInnes I, Genovese MC, Smolen JS, Kremer J, Dougados M, et al. Characterization of Changes in Lymphocyte Subsets in Baricitinib-Treated Patients with Rheumatoid Arthritis in Two Phase 3 Studies. ACR/ARHP-2015 2015; abstr. 1047.
Available from: URL: http://www.acrabstracts.org/abstract/characterization-of-changes-in-lymphocyte-subsets-in-baricitinib-treated-patients-with-rheumatoid-arthritis-in-two-phase-3-studies/ -
Strand V, Sun L, Terres JR, Kannowski CL. Number Needed to Treat to Achieve Minimum Clinically Significant Differences in Patient-Reported Outcomes in Patients Treated with Baricitinib. EULAR-2020 2020; abstr. FRI0048.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/?view=2&c=a&item=2020FRI0048 -
Genovese MC, Dougados M, Schwartzman S, Schlichting D, Beattie S, Xie L, et al. Efficacy of Baricitinib in Patients with Rheumatoid Arthritis Who Failed 2 or More Dmards. EULAR-2018 2018; abstr. SAT0237.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=396681 -
Smolen JS, Kremer J, Gaich C, DeLozier AM, Schlichting D, Xie L, et al. Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis (Ra) and an Inadequate Response to Tumor Necrosis Factor Inhibitors. EULAR-2015 2015; abstr. SAT0349.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=246920 -
Smolen JS, DeLozier AM, de Bono S, Yang L, Gaich C. Work Productivity and Daily Activity in Patients with Rheumatoid Arthritis in Four Phase III Randomized Clinical Trials of Baricitinib. EULAR-2016 2016; abstr. THU0617.
Available from: URL: http://www.abstracts2view.com/eular/view.php?nu=EULAR16L_THU0617 -
Hendricks O, Chrysidis S, Gerwien J, Saifan C, de Leonardis F, Lopez-Romero P, et al. CRP Changes during Bacterial Infections in Baricitinib-Treated Patients with RA. ACR/ARHP-2018 2018; abstr. 1530.
Available from: URL: https://acrabstracts.org/abstract/crp-changes-during-bacterial-infections-in-baricitinib-treated-patients-with-ra/ -
Genovese MC, Kremer JM, Kartman C, Schlichting DE, Xie L, Carmack T, et al. Previous Biologic Disease-Modifying Antirheumatic Drug (bDMARD) Exposure and Efficacy and Safety Analysis from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitors. ACR/ARHP-2015 2015; abstr. 1046.
Available from: URL: http://www.acrabstracts.org/abstract/ -
Smolen JS, Li Z, Klar R, Xie L, Walker D, Ghizdavescu A, et al. Durability and Maintenance of Efficacy Following Prolonged Treatment with Baricitinib. EULAR-2017 2017; abstr. FRI0096.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=348970 -
Kremer J, Dougados M, Genovese MC, Emery P, Yang L, de Bono S, et al. Response to Baricitinib at 4 Weeks Predicts Response at 12 and 24 Weeks in Patients with Rheumatoid Arthritis: Results from Two Phase 3 Studies. ACR/ARHP-2015 2015; abstr. 1050.
Available from: URL: http://www.acrabstracts.org/abstract/response-to-baricitinib-at-4-weeks-predicts-response-at-12-and-24-weeks-in-patients-with-rheumatoid-arthritis-results-from-two-phase-3-studies/ -
Fautrel B, Wu J, Wang D, Haladyj E, van de Laar MAFJ, Takeuchi T. Relative Impact of Pain and Disease Activity on Improvements in Fatigue: Results From 2 Baricitinib Phase 3 Clinical Trials. JCR-J-Clin-Rheumatol 2022;.
PubMed | CrossRef Fulltext -
Hsieh T-Y, Huang W-N, Tony H-P, Balsa A, Winthrop K, Harigai M, et al. Hepatic Safety in Patients with Rheumatoid Arthritis Who Received Isoniazid for Latent Tuberculosis: Post-Hoc Analysis from Phase 3 Baricitinib Studies. EULAR-2018 2018; abstr. FRI0098.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=396804 -
Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, et al. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann-Rheum-Dis 2016;.
PubMed | CrossRef Fulltext -
Strand V, Sebba A, Scardo S, Quebe A, Zaremba-Pechmann L, Taylor PC. Assessing the Relationship of Patient Global Assessment of Disease Activity and Health Related Quality of Life by SF-36 with Other Patient-Reported Outcomes in Rheumatoid Arthritis: Post Hoc Analyses of Data from Phase 3 Trials of Baricitinib. ACR/ARP-2021 2021; abstr. 0741.
Available from: URL: https://acrabstracts.org/abstract/ -
Takeuchi T, Genovese MC, Haraoui B, Li Z, Xie L, Klar R, et al. Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study. ACR/ARHP-2017 2017; abstr. 1821.
Available from: URL: http://acrabstracts.org/abstract/dose-reduction-of-baricitinib-in-patients-with-rheumatoid-arthritis-achieving-sustained-disease-control-results-of-a-prospective-study/ -
I COBII, Gaich C, DeLozier AM, Quebe A, Sun L, Otawa S, et al. Converting Patient-Reported Outcome Measures of Fatigue and Pain to Promis Scores: Data from Phase 3 Baricitinib Rheumatoid Arthritis Trials. EULAR-2018 2018; abstr. THU0106.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=396691 -
Pope JE, Quebe A, Zhu B, Sun L, Gaich CL, de Leonardis F, et al. Assessment of Pain Relief with Baricitinib By Treatment History in Patients with Refractory Rheumatoid Arthritis. ACR/ARHP-2018 2018; abstr. 2531.
Available from: URL: https://acrabstracts.org/abstract/assessment-of-pain-relief-with-baricitinib-by-treatment-history-in-patients-with-refractory-rheumatoid-arthritis/ -
Wells A, Jia B, Xie L, Valenzuela G, Keystone EC, Li Z, et al. Efficacy of Long-term Treatment with Baricitinib 2 Mg in Patients with Active Rheumatoid Arthritis. ACR/ARP-2020 2020; abstr. 0224.
Available from: URL: https://acrabstracts.org/abstract/efficacy-of-long-term-treatment-with-baricitinib-2-mg-in-patients-with-active-rheumatoid-arthritis/ -
Weinblatt M, Genovese MC, Kremer J, Sun L, Patel H, Koch A, et al. Assessment of Early Improvement in Pain and Other ACR Components As Predictors for Achieving Low Disease Activity or Remission in Three Phase 3 Trials of RA Patients Treated with Baricitinib. ACR/ARHP-2017 2017; abstr. 499.
Available from: URL: http://link.adisinsight.com/o6NAm -
Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, et al. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis-Res-Ther 2020;22(1):115.
PubMed | CrossRef Fulltext -
van de Laar MAFJ, Pope J, Lee Y, Fautrel B, Ikeda K, Quebe A, et al. Contribution of Pain Relief to Function, Fatigue, and Quality of Life When In? ammation Is Controlled in Patients with Rheumatoid Arthritis . ACR/ARHP-2019 2019; abstr. 0417.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Ernest II CS, O?Brien L, Radtke D, Heathman M, Rooney T, Macias W, et al. Bari-00074565. ACR/ARHP-2016 2016; abstr. 1584.
Available from: URL: http://acrabstracts.org/abstract/bari-00074565/ -
Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, et al. Characterization and changes of lymphocyte subsets in baricitinib-treated patients with rheumatoid arthritis: an integrated analysis. Arthritis-Rheumatol 2018;.
PubMed | CrossRef Fulltext -
Curtis JR, Kavanaugh A, van der Heijde D, Muram D, Alam J, Beattie S, et al. Effect of Starting Dose of Baricitinib in Achieving Sustained Low Disease Activity. EULAR-2017 2017; abstr. FRI0089.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=349483 -
Winthrop KL, Genovese MC, Harigai M, Chen L, Dickson CL, Hyslop DL, et al. Serious Infection and Associated Risk Factors in Patients with Moderate to Severe Rheumatoid Arthritis Treated with Baricitinib. EULAR-2017 2017; abstr. OP0248.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=348994
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Eli Lilly | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Argentina, Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, India, Israel, Italy, Mexico, Netherlands, Poland, Puerto-Rico, Spain, Switzerland, Turkey, United-Kingdom, USA |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
|
Asan medical center
Chang Keun Lee
show details
|
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|
South-Korea |
|
Eli Lilly and Company
Avda de la Industria 30
show details
Alcobendas Madrid 28108 Spain Tel: 34916635354 Fax: 34916635327 EU_Lilly_Clinical_Trials@lilly.com |
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|
USA |
|
Eli Lilly and Company
Avda de la Industria 30
show details
Alcobendas Madrid 28108 Spain Tel: 34916635354 Fax: 34916635327 EU_Lilly_Clinical_Trials@lilly.com |
Madrid | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Afula | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Ahmedabad | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Albany, New York | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Almelo | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Amsterdam | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Ankara | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Antalya | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Ashkelon | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Attavar, Mangalore | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Aurora, Colorado | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Bahia Blanca | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Bangalore | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Barcelona | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Beer Yaakov | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Berlin | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Bethlehem, Pennsylvania | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Bilboa | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Boise, Idaho | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Boynton Beach, Florida | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Bradford, West Yorkshire | United-Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Brussels | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Buenos Aires | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Bydgoszcz | Poland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Caguas | Puerto-Rico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Camperdown, New South Wales | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Chesapeake, Virginia | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Chihuahua | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Cincinnati, Ohio | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Columbus, Ohio | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Daejeon |
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|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Danbury, Connecticut | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Denizli | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Denver, Colorado | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Dresden | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Edirne | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Eskisehir | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Firenze | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Fitzroy, Victoria | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Franklin, Wisconsin | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Frederiksberg | Denmark |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Freehold, New Jersey | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Fresno, California | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Garran, Australian Capital Territory | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Gaziantep | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Gdansk | Poland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Glendale, Arizona | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Glostrup | Denmark |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Graz | Austria |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Guadalajara | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Gurgaon | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Haifa | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Hamburg | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Hamilton, Ontario | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Hartsdale, New York | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Heidelberg | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Heraklion | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Hildesheim | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Houston, Texas | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Hyderabaad | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Indianapolis, Indiana | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Istanbul | Turkey |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Jaipur | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kalamazoo, Michigan | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kennewick, Washington | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kfar Saba | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kifissia | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kochin | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kogarah, New South Wales | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Kolkata | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Lansing, Michigan | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Larissa | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Lausanne | Switzerland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Lewes, Delaware | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Liège | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | London, Greater London | United-Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Longmont, Colorado | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Lubbock, Texas | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Mar Del Plata | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Maroochydore, Queensland | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Milano | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Mississauga, Ontario | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Mons | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Monterrey | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Montpellier | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Mumbai | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Myrtle Beach, South Carolina | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Nadarzyn | Poland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Naples, Florida | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Nassau Bay, Texas | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | New Delhi | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Nijmegen | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | North Shields, Tyneside | United-Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Oklahoma City, Oklahoma | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Orlando, Florida | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Orleans | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Osijek | Croatia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Palo Alto, California | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Paris | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Peoria, Arizona | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Petah Tikva | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Philadelphia, Pennsylvania | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Pisa | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Poitiers | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Portland, Oregon | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Prairie Village, Kansas | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Quebec City, Quebec | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Rennes | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Rochester, New York | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Rome | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Rosario | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Rouen | France |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Santander | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Santurce | Puerto-Rico |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Secunderabad | India |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Sevilla | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | St Louis, Missouri | USA |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Tampa, Florida | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Tel Aviv | Israel |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Toronto, Ontario | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Torquay, Cnwll | United-Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Tours | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Trumbull, Connecticut | USA |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Tucuman | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Tulsa, Oklahoma | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Ubbergen | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Upland, California | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Valencia | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Vancouver, Washington | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Vienna | Austria |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Villajoyosa | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Villars-Sur-Glâne | Switzerland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Würzburg | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Warsaw | Poland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Webster, Texas | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Winnipeg, Manitoba | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Wyomissing, Pennsylvania | USA |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Zürich | Switzerland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-87 | Zagreb | Croatia |
| Incyte Corporation |
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| Lilly Korea |
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NIHR Comprehensive Clinical Research Network
Fairburn House, Leeds
show details
Fairbairn House 71-75 Clarendon Road Leeds West Yorkshire LS2 9PH England ccrn.industryrecruitment@nihr.ac.uk |
Leeds | England |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 07 Dec 2022 | Results | Results from NCT01710358 and NCT01721044 assessing the relative impact of pain and disease activity on improvements in fatigue, published in the JCR: Journal of Clinical Rheumatology Updated 09 Dec 2022 |
| 09 Nov 2021 | Results | Results assessing effects of Baricitinib on fatigue that are influenced by disease activity and those that are independent of disease activity in patients from the RA-BEAM and RA-BEACON trials, presented at the ACR Convergence 2021 Updated 07 Jan 2022 |
| 09 Nov 2021 | Results | Results of post-hoc analysis of 3 studies (RA-BEGIN (NCT01711359); RA-BEAM (NCT01710358) & RA-BEACON (NCT01721044)) assessing the relative importance of PROs on the Patient Global Assessment of Disease Activity (PtGA) and health-related quality of life (HRQoL) and whether these differ in patients with good disease control compared with those not in low disease activity (LDA) or remission in different patient populations, presented at the ACR Convergence 2021. Updated 06 Jan 2022 |
| 27 Oct 2021 | Results | Results (n=3770) assessing safety of baricitinib for the treatment of rheumatoid arthritis from long-term extension study and integrated database (NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT02265705, NCT01721044, NCT01721057, NCT01711359 and NCT01885078), published in the Annals of the Rheumatic Diseases. Updated 10 Nov 2021 |
| 09 Nov 2020 | Results | Results of post-hoc analysis of two studies (RA-BEACON & RA-BUILD) presented at the 84th American College of Rheumatology and the 55th Association of Rheumatology Health Professionals . Updated 18 Jan 2021 |
| 09 Nov 2020 | Results | Results from trials RA-BUILD, RA-BEACON and RA-BEYOND presented at the 84th American College of Rheumatology and the 55th Association of Rheumatology Health Professionals Updated 15 Jan 2021 |
| 09 Nov 2020 | Results | Results reporting the NNT and NNH of Janus kinase (JAK) inhibitors approved in the US, in RA patients who have an inadequate response to TNF inhibitors presented at the 84th American College of Rheumatology and the 55th Association of Rheumatology Health Professionals Updated 13 Jan 2021 |
| 06 Jun 2020 | Results | Results of an analysis assessing number needed to treat (NNT) to report improvements minimum clinically important differences in multiple patient-reported outcomes at week 12 after treatment with Baricitinib 4mg in RA-BEAM and BARI 2 mg or BARI 4 mg in RA-BEACON studies presented at the 21st Annual Congress of the European League Against Rheumatism Updated 29 Jun 2020 |
| 15 May 2020 | Results | Results of post-hoc analysis from phase 3 studies (RA-BUILD, RA-BEACON, RA-BEAM and RA-BEGIN) assessing the impact of interruptions and drug retreatment on efficacy and safety outcomes, published in the Arthritis Research and Therapy. Updated 29 Jun 2021 |
| 13 Nov 2019 | Results | Results assessing response patterns of BARI 2-mg by using data from this study presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting. Updated 10 Feb 2020 |
| 13 Nov 2019 | Results | Results of post hoc analysis of phase III trials assessing pain reduction in opoid users and non users presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 06 Feb 2020 |
| 13 Nov 2019 | Results | Results, post-hoc analysis of the pooled data from three phase III trials to quantify the contribution of pain relief to other patient- reported outcomes, presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 05 Feb 2020 |
| 18 Sep 2019 | Biomarker Update | Biomarkers information updated Updated 07 Nov 2021 |
| 18 Sep 2019 | Other trial event | Last checked against Korea record. Updated 18 Sep 2019 |
| 26 Jun 2019 | Other trial event | Last checked against the European Clinical Trials Database record. Updated 26 Jun 2019 |
| 15 Jun 2019 | Results | Results of pooled analysis from nine studies of Baricitinib treated rheumatoid arthritis patients presented at the 20th Annual Congress of the European League Against Rheumatism Updated 21 Jun 2019 |
| 06 Jun 2019 | Other trial event | According to an Eli Lilly media release, data from this trial will be presented at the upcoming Annual European Congress of Rheumatology (EULAR 2019) in Madrid from June 12-15, 2019. Updated 11 Jun 2019 |
| 24 Oct 2018 | Results | Results presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 23 Nov 2018 |
| 24 Oct 2018 | Results | Results of pooled analysis from the RA-BEAM, RA-BUILD and RA-BEACON evaluating CRP levels during bacterial infections in RA patients treated with Baricitinib or placebo (PBO), presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting. Updated 21 Nov 2018 |
| 15 Sep 2018 | Results | Results published in The Journal of Rheumatology Updated 25 Sep 2018 |
| 29 Jul 2018 | Results | Results of pooled data from 3 phase 3 trials (RA-BEAM, RA-BUILD, and RA-BEACON) published in the Arthritis and Rheumatology Updated 03 Aug 2018 |
| 16 Jun 2018 | Results | Results of pooled data from three phase 3 trial (RA-BEAM, RA-BUILD and RA-BEACON ), were presented at the 19th Annual Congress of the European League Against Rheumatism. Updated 17 Jul 2018 |
| 16 Jun 2018 | Results | Results presented at the 19th Annual Congress of the European League Against Rheumatism Updated 16 Jul 2018 |
| 16 Jun 2018 | Results | Results presented at the 19th Annual Congress of the European League Against Rheumatism Updated 15 Jul 2018 |
| 16 Jun 2018 | Results | Results determining PROMIS physical function scores converted from HAQ-DI in RA-BEAM and RA-BEACON presented at the 19th Annual Congress of the European League Against Rheumatism Updated 14 Jul 2018 |
| 16 Jun 2018 | Results | Results of PROMIS patient reported outcome scores in RA-BEAM and RA-BEACON presented at the 19th Annual Congress of the European League Against Rheumatism Updated 14 Jul 2018 |
| 01 Jun 2018 | Other trial event | According to an Eli Lilly media release, U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Updated 07 Jun 2018 |
| 01 May 2018 | Other trial event | According to the Incyte Corporation media release, US. Food and Drug Administration (FDA) convened its Arthritis Advisory Committee to discuss the resubmission of the baricitinib NDA. The FDA action date for baricitinib is in June 2018. Updated 04 May 2018 |
| 23 Apr 2018 | Other trial event | According to an Eli Lilly media release, the Arthritis Advisory Committee of the FDA unanimously supported the efficacy of the 4-mg dose of baricitinib, however it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles. Updated 26 Apr 2018 |
| 23 Apr 2018 | Other trial event | According to an Eli Lilly media release, the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib (oral, once-daily) for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. Updated 26 Apr 2018 |
| 07 Mar 2018 | Other trial event | Patients were not recruited from India ase per the results published in EudraCT. Updated 03 Aug 2018 |
| 07 Mar 2018 | Other trial event | Patients were not recruited from Croatia, Puerto Rico and South Africa, accroding to results published in EudraCT. Updated 03 Aug 2018 |
| 20 Feb 2018 | Results | Results of pooled analysis of NCT00902486, NCT01469013, NCT01185353, NCT01721044, NCT01721057, NCT01711359, NCT01710358 and NCT01885078 trials assessing the effects of baricitinib on the lipid profile, lipoprotein particle size and number, and GlycA published in the Annals of the Rheumatic Diseases Updated 26 Feb 2018 |
| 15 Feb 2018 | Other trial event | According to an Incyte Corporation media release, in Dec 2017, Eli Lilly announced that they have resubmitted the New Drug Application (NDA) for baricitinib to the U.S.FDA. This was classified as a Class II resubmission, which began a new six-month review cycle. Updated 22 Feb 2018 |
| 03 Feb 2018 | Results | Results of post hoc subgroup analysis assessing effects of baseline characteristics, including prior bDMARD exposure, on baricitinib efficacy and safety, were published in the Rheumatology. Updated 16 Feb 2018 |
| 19 Jan 2018 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 19 Jan 2018 |
| 08 Nov 2017 | Results | Results assessing effects of baricitinib dose step down in patients who achieved sustained disease control with baricitinib 4 mg using patient data from RA-BUILD, RA-BEAM, RA-BEACON and RA-BEGIN trials presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 18 Dec 2017 |
| 08 Nov 2017 | Results | Results assessing early improvement in ACR components as predictors of low disease activity in patients from three phase III trials (RA-BEAM, RA-BEACON and RA-BUILD), presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 13 Dec 2017 |
| 30 Aug 2017 | Other trial event | According to an Incyte Corporation media release, company will file resubmission of NDA to FDA before end of January 2018. Updated 04 Sep 2017 |
| 03 Jul 2017 | Other trial event | According to an Eli Lilly media release, based on the data from four Phase III trials Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies. Updated 07 Jul 2017 |
| 17 Jun 2017 | Results | Results assessing the incidence of serious infection events in Baricitinib treated RA patients from across eight studies (n=3492), presented at the 18th Annual Congress of the European League Against Rheumatism Updated 07 Jul 2017 |
| 17 Jun 2017 | Results | Results of post-hoc analysis of two phase II studies ( RA-BEACON and RA-BUILD) and their extension study (RA-BEYOND), presented at the 18th Annual Congress of the European League Against Rheumatism Updated 04 Jul 2017 |
| 17 Jun 2017 | Results | Results of post-hoc analysis, presented at the 18th Annual Congress of the European League Against Rheumatism Updated 03 Jul 2017 |
| 17 Jun 2017 | Results | Results of pooled analysis assessing effect of dose reduction of baricitinib from RA-BEAM, RA-BUILD, RA-BEACON trials presented at the 18th Annual Congress of the European League Against Rheumatism. Updated 02 Jul 2017 |
| 17 Jun 2017 | Results | Results assessing durability and maintenance of efficacy at week-96 from RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON trials and a long-term extension study presented at the 18th Annual Congress of the European League Against Rheumatism Updated 01 Jul 2017 |
| 17 Jun 2017 | Results | Results of post hoc analysis of two trials (NCT01710358 and NCT01721044) evaluating the effect of baricitinib treatment on pain reduction compared to adalimumab or placebo presented at the 18th Annual Congress of the European League Against Rheumatism Updated 30 Jun 2017 |
| 14 Apr 2017 | Other trial event | According to an Incyte Corporation media release, the company will resubmit NDA based on further discussions with the FDA. Updated 19 Apr 2017 |
| 14 Apr 2017 | Other trial event | According to an Incyte Corporation media release, the U.S. FDA has issued a complete response letter for the NDA of baricitinib for the treatment of moderate-to-severe rheumatoid arthritis, based on data from four Phase III trials (RA-BEGIN, RA-BUILD, RA-BEACON and RA-BEAM). The letter indicates that the FDA is unable to approve the application in its current form and additional clinical data are needed to determine the most appropriate doses and safety. Updated 19 Apr 2017 |
| 13 Feb 2017 | Other trial event | The European Commission has granted marketing authorisation for Olumiant (baricitinib) 4 mg and 2 mg film-coated tablets in Europe for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs), according to an Eli Lilly media release. Updated 14 Feb 2017 |
| 16 Dec 2016 | Other trial event | According to an Eli Lilly media release, the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the approval of baricitinib (Olumiant) for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs), based on data from RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND trial Updated 23 Dec 2016 |
| 16 Nov 2016 | Results | Pooled results from 7 phase II and phase III studies presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals. Updated 25 Jan 2017 |
| 02 Nov 2016 | Results | Results from patient-reported outcomes and health-related quality of life published in an Eli Lilly media release. Updated 15 Nov 2016 |
| 31 Oct 2016 | Results | Results published in the Annals of the Rheumatic Diseases Updated 18 Nov 2016 |
| 08 Jul 2016 | Other trial event | New source identified and integrated. (Japan Pharmaceutical Information Center - Clinical Trials Information; JapicCTI132156) Updated 08 Jul 2016 |
| 11 Jun 2016 | Results | Results of integrated safety analysis of this and other eight studies (n=3464) presented at the 17th Annual Congress of the European League Against Rheumatism. Updated 02 Sep 2016 |
| 11 Jun 2016 | Results | Results from this and other three (RA-BEGIN, RA-BEAM, RA-BUILD, ) trial presented at the 17th Annual Congress of the European League Against Rheumatism Updated 22 Jul 2016 |
| 09 May 2016 | Other trial event | According to an Incyte Corporation media release, an MAA has been submitted to the EMA for the approval of baricitinib for the treatment of rheumatoid arthritis. Updated 18 May 2016 |
| 31 Mar 2016 | Results | Results published in the New England Journal of Medicine Updated 05 Apr 2016 |
| 31 Mar 2016 | Results | Results from this trial were published in the New England Journal of Medicine, according to an Eli Lilly media release. Updated 04 Apr 2016 |
| 31 Mar 2016 | Results | Results published in an Eli Lilly media release. Updated 04 Apr 2016 |
| 19 Jan 2016 | Other trial event | According to an Eli Lilly media release, the company has submitted an NDA to the US FDA for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis. Updated 22 Jan 2016 |
| 11 Nov 2015 | Results | Results from this and RA-BUILD trial were presented at the 79th American College of Rheumatology and the 50th Annual Meeting of the Association of Rheumatology and Health Professionals Updated 09 Feb 2016 |
| 11 Nov 2015 | Results | Results of RA-BUILD and RA-BEACON studies assessing lymphocyte subsets presented at the 79th American College of Rheumatology and the 50th Annual Meeting of the Association of Rheumatology and Health Professionals. Updated 08 Feb 2016 |
| 11 Nov 2015 | Results | Post-hoc exploratory analysis was presented at the 79th American College of Rheumatology and the 50th Annual Meeting of the Association of Rheumatology and Health Professionals. Updated 05 Feb 2016 |
| 07 Nov 2015 | Other trial event | According to an Eli Lilly media release, results from this study will be presented at scientific meetings and published in peer-reviewed journals in 2016. Updated 12 Nov 2015 |
| 13 Jun 2015 | Results | Results presented at the 16th Annual Congress of the European League Against Rheumatism. Updated 22 Jul 2015 |
| 13 Jun 2015 | Results | Results (patient-reported outcomes) presented at the 16th Annual Congress of the European League Against Rheumatism. Updated 22 Jul 2015 |
| 28 May 2015 | Other trial event | According to an Eli Lilly media release, data from this trial will be presented at the the EULAR Congress 2015. Updated 30 May 2015 |
| 23 Feb 2015 | Other trial event | According to an Eli Lilly media release, detailed data from this trial is expected to be presented at scientific meetings in 2015. Updated 25 Feb 2015 |
| 09 Dec 2014 | Results | Top-line results published in an Eli Lilly media release. Updated 16 Dec 2014 |
| 09 Dec 2014 | Endpoint met | Primary endpoint has been met (Proportion of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)), according to an Eli Lilly media release. Updated 16 Dec 2014 |
| 30 Oct 2014 | Other trial event | As per the media release, this is one of the four phase III trials, data from this study is expected to be reported by Lilly in late 2014 or early 2015. Updated 15 Dec 2014 |
| 15 Sep 2014 | Status change - completed | Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov. Updated 18 Sep 2014 |
| 21 May 2014 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting, as per ClinicalTrials.gov record. Updated 12 Jun 2014 |
| 31 Mar 2014 | Other trial event | New source identified and integrated (Clinical Research Information Service (CriS) - Republic of Korea; KCT0001004). Updated 03 Apr 2014 |
| 05 Feb 2014 | Completion date | Planned End Date changed from 1 Jul 2014 to 1 Sep 2014, as per ClinicalTrials.gov record. Updated 03 Apr 2014 |
| 05 Feb 2014 | Other trial event | Last checked against United Kingdom Clinical Research Network record. Updated 28 Mar 2014 |
| 09 Sep 2013 | Completion date | Planned End Date changed from 1 Nov 2014 to 1 Jul 2014 as reported by ClinicalTrials.gov. Updated 14 Sep 2013 |
| 14 Jul 2013 | Other trial event | New source identified and integrated (United Kingdom Clinical Research Network: 13606). Updated 16 Jul 2013 |
| 19 Jan 2013 | Other trial event | New source identified and integrated (European Clinical Trials Database, EudraCT2012-002323-15). Updated 20 Jan 2013 |
| 14 Jan 2013 | Status change - recruiting | Status changed from not yet recruiting to recruiting as reported by European Clinical Trials Database. Updated 20 Jan 2013 |
| 22 Nov 2012 | New trial record | New trial record Updated 22 Nov 2012 |
Table of Contents
References
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Eli Lilly. Lilly and Incyte Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib in Moderate to Severe Rheumatoid Arthritis. Media-Rel 2014;.
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