A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Latest Information Update: 30 Jan 2023
At a glance
- Drugs Tocilizumab (Primary) ; Corticosteroids; Methotrexate; Prednisone
- Indications Giant cell arteritis
- Focus Registrational; Therapeutic Use
- Acronyms GiACTA
- Sponsors Genentech; Roche
- 16 Nov 2022 Results evaluating longitudinal effects of both glucocorticoids (GCs) and tocilizumab, on hemoglobin A1c (HbA1c) during GC tapering, published in the Arthritis and Rheumatology
- 14 Nov 2022 Results of post-hoc analysis assessing glucocorticoid toxicity in the treatment of giant cell arteritis, presented at the ACR Convergence 2022.
- 01 Dec 2021 Results published in the American Journal of Respiratory and Critical Care Medicine.
Most Recent Events
Trial Overview
Outcome
Purpose
This study is evaluating the efficacy and safety of tocilizumab in participants with Giant cell arteritis. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone
Comments
Based on data from this trial, Actemra/RoActemra (tocilizumab) has been approved in USA, New Zealand, Canada and the European Union for the treatment of giant cell arteritis.
Based on the results from this and MRA632JP study, the company obtained an approval for Actemra 162mg Syringe for subcutaneous (SC) Injection and Actemra 162mg Auto-Injector for SC Injection by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional indications of Takayasu arteritis (TAK) and giant cell arteritis (GCA) that have not responded sufficiently to existing therapies.
Primary Endpoints
Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)
description: Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.
time_frame: Week 52 [1]
Other Endpoints
Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) [ Time Frame: Week 52]
Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.
Time to First GCA Disease Flare [ Time Frame: Up to 52 weeks ]
Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal.
Total Cumulative Prednisone Dose [ Time Frame: Up to 52 weeks ]
The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented.
Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52 [ Time Frame: Baseline, Week 52 ]
The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy.
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52 [ Time Frame: Baseline, Week 52 ]
Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab [ Time Frame: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) ]
AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL).
Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab [ Time Frame: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) ]
Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL).
Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab [ Time Frame: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) ]
Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL.
Minimum Observed Serum Concentration (Ctrough) of Tocilizumab [ Time Frame: Predose (Hour 0) at Baseline and Week 52 ]
Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL.
Serum Interleukin-6 (IL-6) Level [ Time Frame: Baseline and Week 52 ]
Serum Soluble IL-6 Receptor (sIL-6R) Level [ Time Frame: Baseline and Week 52 ]
Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline and Week 52 ]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
C-Reactive Protein (CRP) Level [ Time Frame: Baseline and Week 52 ]
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Percentage of Participants With Anti-Tocilizumab Antibodies [ Time Frame: Baseline up to Week 52 ]
All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported. [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Giant cell arteritis | treatment | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT01791153 | C-reactive protein (CRP) | Eligibility Criteria, Outcome Measure |
| interleukin 6 receptor | Outcome Measure | |
| Interleukin-6 (IL-6) | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 250
Actual: 251
- Sex male & female
- Age Group ≥ 50 (mean 69 ± 8.2) years; adult; elderly
Patient Inclusion Criteria
- Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large-vessel vasculitis by angiography or cross-sectional imaging - New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than [>] 6 weeks before baseline and previous treatment with >/= 40 milligrams per day prednisone [or equivalent] for at least 2 consecutive weeks at any time) GCA - Active disease (presence of clinical signs and symptoms [cranial or PMR] and ESR >/=30 mm/hour or CRP >/=1 mg/dL) within 6 weeks of baseline visit
Patient Exclusion Criteria
- Major surgery within 8 weeks prior to screening or planned within 12 months after randomization - Transplanted organs (except corneas with transplant performed >3 months prior to screening) - Major ischemic event, unrelated to GCA, within 12 weeks of screening - Prior treatment with any of the following: investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening; cell-depleting therapies including investigational agent; intravenous (IV) gamma globulin or plasmapheresis within 6 months of baseline; alkylating agents or with total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2 weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib; cyclophosphamide within 6 months of baseline; >100 milligrams of daily IV methylprednisolone within 6 weeks of baseline - Participants requiring systemic glucocorticoids for conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed glucocorticoid taper regimen and/or to assessment of efficacy in response to the test article - History of severe allergic reactions to monoclonal antibodies or to prednisone - Evidence of serious uncontrolled concomitant disease (for example, cardiovascular, respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or gastrointestinal [GI] disease) - Current liver disease, as determined by the investigator - History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation - Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other infection - Primary or secondary immunodeficiency - Evidence of malignancies diagnosed within previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured) - Inadequate hematologic, renal or liver function - Positive for hepatitis B or hepatitis C infection
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT01791153 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2011-006022-25 | European Clinical Trials Database |
| WA28119 | Roche |
Organisations
- Sponsors Genentech; Roche
- Affiliations Genentech; Roche
Trial Dates
-
Initiation Dates
Actual : 22 Jul 2013
-
Primary Completion Dates
Planned : 01 Apr 2018
Actual : 11 Apr 2016
-
End Dates
Planned : 30 Apr 2018
Actual : 04 Jun 2018
Substudies/Extensions
This study contain a 104-week open label extension study.
Pharmacokinetic Substudy to assess the PK of TCZ in GCA patients. This substudy is planned to be conducted at selected sites (see protocol WA28119, section 3.1.1.7 and section 3.4.4)
Other Details
- Design double-blind; multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Austria; Belgium; Canada; Denmark; England; France; Germany; Italy; Netherlands; Norway; Poland; Portugal; Scotland; Spain; Sweden; United Kingdom; USA
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Corticosteroids | Intravenous |
-
|
| Methotrexate |
-
|
-
|
| Prednisone | Oral | Capsule, Tablet |
| TocilizumabPrimary Drug | Subcutaneous | Injection |
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Participants will receive tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants will receive prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52. Drug: Tocilizumab (Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.) Other Name: RoActemra, Actemra, RO4877533 Drug: Prednisone (Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.) Drug: Tocilizumab Placebo (Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.) Drug: Prednisone Placebo (Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.)
Part 1: Tocilizumab qw + 26 weeks prednisone taper
Participants will receive tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants will receive prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52. Drug: Tocilizumab (Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.) Other Name: RoActemra, Actemra, RO4877533 Drug: Prednisone (Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.) Drug: Prednisone Placebo (Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.)
Part 2: Open-Label Tocilizumab qw
Participants without sustained remission at Week 52 will receive open-label tocilizumab at a dose of 162 mg as SC injection qw and/or corticosteroids and/or methotrexate at the discretion of the investigator for a maximum of 104 weeks. Drug: Tocilizumab (Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.) Other Name: RoActemra, Actemra, RO4877533 Drug: Corticosteroids (Participants without sustained remission at Week 52 will receive corticosteroids at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.) Drug: Methotrexate (Participants without sustained remission at Week 52 will receive methotrexate at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.)
Part 1: Placebo + 26 weeks prednisone taper
Participants will receive tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants will receive prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52. Drug: Prednisone (Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.) Drug: Tocilizumab Placebo (Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.) Drug: Prednisone Placebo (Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.)
Part 1: Placebo + 52 weeks prednisone taper
Participants will receive tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to a protocol-defined schedule. Participants will receive prednisone tapering oral daily doses for 52 weeks. Drug: Prednisone (Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.) Drug: Tocilizumab Placebo (Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.) Drug: Prednisone Placebo (Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.)
Results
Therapeutic efficacy
The phase III GiACTA trial met the primary endpoint with a significant increase in the proportion of patients achieving sustained remission at one year (56% in the weekly treatment group [QW; p < 0.0001] and 53.1% in the bi-weekly treatment group [Q2W; p < 0.0001]) versus 14% in a six-month steroid taper regimen given alone. The secondary endpoint were also met with a significant increase in the proportion of patients achieving sustained remission at one year (56% [QW; p < 0.0001] and 53.1% [Q2W; p = 0.0002]) compared to 17.6% with a 12-month steroid taper regimen given alone. The data was obtained from 251 patients randomised 1:1:2:1 to 4 groups: A, short-course prednisone (26-week prednisone taper + weekly subcutaneous [SC] placebo); B, long-course prednisone (52-week prednisone taper + weekly SC placebo); C, weekly SC TCZ 162 mg + 26-week prednisone taper; D, every other week SC tocilizumab (TCZ) 162 mg + 26-week prednisone taper [3] [4] . Updated results from the trial demonstrated that the SF- 36 MCS scores in all 50 patients who maintained treatment- free clinical remission in part 2 had diverged between the TCZ and palcebo groups as early as 36 weeks after baseline, with greater improve-ments evident in the TCZ group. The difference in least squares mean (LSM) change between TCZ and placebo was statistically significant at week 52 (p = 0.016) and maintained at weeks 100 ( p = 0.023) and 156 ( p = 0.0019). The LSM difference (95% CI) between TCZ and placebo at weeks 52, 100, and 156 was 5.6 (1.1- 10.2), 6.5 (0.9- 12.1), and 7.4 (2.9- 11.9), respectively, exceeding the MCID. Among patients who maintained treatment- free clinical remission during part 2 of GiACTA trial those originally assigned to receive TCZ plus a prednisone taper during part 1 maintained statistically significant and clinically meaningful improvements in 36 item Short- Form Health Survey (SF- 36) Mental Component Summary (MCS) up to week 156 compared with those originally assigned to receive placebo plus a prednisone taper in part 1. New onset GCA at baseline was reported in TCZ QW group (47%), TCZ Q2W group (53%), and in the pooled PBO group (46%), the remaining patients had relapsing GCA. Median time for first flare are over 3 years was reported to be longer for patients with TCZ treatment in part 1 than those with patients in PBO group. Among patients in TCZ groups, the median time for first flare was longer with QW than Q2W dosing for both the new- onset and the relapsing subgroups. Higher proportions of patients in the TCZ QW group (new- onset, 49%; relaps-ing, 47%) than the pooled PBO group (new- onset, 28%; relapsing, 31%) and the TCZ Q2W group (new- onset, 27%; relapsing, 35%) remained flare free during the entire 3- year study. Kaplan- Meier analysis reported a clear separation between the TCZ QW and pooled PBO groups over 3 years for patients with new onset and relapsing GCA. Separation between the TCZ QW and TCZ Q2W groups was also reported over 3 years in patients with new onset and relapsing GCA [5] [6] . Previous results from the part-2 of the study, indicated nearly half the patients treated with tocilizumab QW maintained clinical remission for the entirely of part 2, though flares still occurred in the remaining patients once they discontinued tocilizumab treatment. Among patients who maintained clinical remission in part 2, higher proportions of those originally assigned to tocilizumab were treatment-free compared with those originally assigned to placebo. Among the 81 tocilizumab QW and 36 tocilizumab Q2W patients in clinical remission at week 52, 47% and 36% patients, respectively, maintained clinical remission during part 2. Of these 51 original tocilizumab pateints, 65% were treatment-free (no tocilizumab and no glucocorticoid treatment), which was higher than the treatment-free proportion of original placebo patients who maintained clinical remission in part 2 (45%). Median time to first flare while not receiving tocilizumab was longer for patients in the original tocilizumab groups (tocilizumab QW, 575 days; tocilizumab Q2W, 428 days) than for patients in the original placebo groups (placebo + 26, 162 days; placebo + 52, 295 days); tocilizumab QW patients remained flare-free the longest. Retreatment with tocilizumab (with or without GC) for flare was effective for restoring clinical remission in part 2. Cumulative glucocorticoid dose over the three-year study was lowest in the tocilizumab QW group (median dose [mg/day]: tocilizumab QW, 2647; tocilizumab Q2W, 3782; placebo + 26, 5248; placebo + 52, 5323). Results were reported from 215 of 250 patients enrolled in the study [7] . Results from univariate analysis indicated 45% of patients were responders of which 27% were treated in the placebo + prednisone group and 58% in the tocilizumab+prednisone group. In contrast, 44% of patients experienced treatment failure: 66% in the placebo +prednisone group and 30% in the tocilizumab+prednisone group. The other 10% of patients were non-responders. Female sex and lower baseline SF-36 Physical Component Summary (PCS), Mental Component Summary, and FACIT-Fatigue scores were associated with treatment failure among placebo + prednisone treated patients, whereas higher patient global assessment of disease activity scores and lower SF-36 PCS, FACIT-Fatigue, and EQ-5D scores were associated with treatment failure among the tocilizumab+prednisone treated patients. Among tocilizumab+prednisone treated patients, no treatment response difference according to sex was observed. Age, previous relapse, starting prednisone dose, and GCA clinical features (cranial or polymyalgia rheumatica symptoms) were not associated with treatment failure in either group based on univariate analysis. Multivariate logistic regression demonstrated that placebo +prednisone treatment, female sex, worsen FACIT-Fatigue scores at baseline, and historical C-reactive protein > 2.5 mg/dL all independently increased the risk for treatment failure [8] [9] .
Adverse events
Giant cell arteritis
Results from the phase III GiACTA study demonstrate that tocilizumab had a generally well tolerated adverse events (AEs) profile and the safety profile of the tocilizumab groups was generally consistent with the documented safety profile of tocilizumab in other indications. Incidence of AEs was similar in the 4 treatment arms. No deaths or new vision loss incidents were reported over the period of observation. Fewer patients reported serious adverse events in the tocilizumab weekly (15%) and biweekly groups (14.3%) than in the placebo combined with a 26-week steroid taper regimen (22%) and placebo combined with a 52-week steroid taper regimen groups (25.5%). The data was obtained from 251 patients randomised 1:1:2:1 to four groups: a, short-course prednisone (26-week prednisone taper + weekly subcutaneous [SC] placebo); B, long-course prednisone (52-week prednisone taper + weekly SC placebo); C, weekly SC TCZ 162 mg + 26-week prednisone taper; D, every other week SC TCZ 162 mg + 26-week prednisone taper [1] [3] . Updated results from part-2 study showed rates of serious adverse events per 100 patient-years over 3 years (double-blind period + part 2) were comparable for patients who never received tocilizumab (23.2) and who received ≥ 1 dose of tocilizumab (25.4), and rates of serious infections were 4.6 and 3.5 per 100 patient-years, respectively. No new safety signals were observed with tocilizumab exposure in glucocorticoid patients during the three-year study. No patients with tocilizumab-induced ADA experienced anaphylaxis, hypersensitivity reactions, or injection site reactions, and none withdrew because of lack of efficacy. Results were reported from 215 of 250 patients enrolled in the study [10] [7] .
Pharmacokinetics
Three year results from the phase III GiACTA trial demonstrated that treatment with Tocilizumab (TCZ) during the first 4 weeks of dosing, TCZ C trough levels were comparable in the TCZ break group and the part 1 prednisone taper (TCZ- QW) group and part 2 [11]
Pharmacodynamics
Three year results from the phase III GiACTA trial demonstrated that patients who experienced lare while on Tocilizumab (TCZ) had low levels of CRP and ESR. In part 2 of the trial, TCZ C trough and PD biomarkers after the first initial 4 doses were comparable at steady state to the values at the end of part 1. Patients who experienced lare while not receiving TCZ had higher levels of CRP and ESR compared to those who experienced lare on TCZ, where lares occurred despite low levels of these inflammatory markers [11]
Immunogenicity
In the phase III trial, treatment with tocilizumab developed anti-drug antibodies (ADA) in patients with giant cell arteritis. ADA in evaluable patients in part 1, was developed in one our of 95 atients and three out of 46 patients after the treatment QW and Q2W dosing, respectively. One of 49 (2.0%) in the PBO+26 and one of 47 (2.1%) in PBO+52 groups, respectively, tested positive for ADA but had not received tocilizumab and were considered false positives. Tocilizumab -induced ADA developed in 13 of patients (6.7%) postbaseline (four during part 1, nine during part 2). Of these 13 patients, 8 (4.1%) had ADA with neutralizing potential and 1 (0.5%) had IgE ADA. Most tocilizumab -induced ADA were transient [12] [10] .
2021-01-06 11:18:00.813
Publications
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Genentech. Positive Phase III Results of Genentechs Actemra (Tocilizumab) for the Treatment of Giant Cell Arteritis Published in New England Journal of Medicine. Media-Rel 2017;.
Media Release -
Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Efficacy and Safety of Tocilizumab in Patients with Giant Cell Arteritis: Primary and Secondary Outcomes from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. ACR/ARHP-2016 2016; abstr. 911.
Available from: URL: http://link.adisinsight.com/Ry5m4 -
Genentech. Phase III GiACTA Study Shows Genentechs Actemra(R) is Superior to Steroids Alone in Maintaining Steroid-Free Remission for People with Giant Cell Arteritis. Media-Rel 2016;.
Media Release -
Stone J, Spotswood H, Unizony S, Aringer M, Blockmans D, Brouwer E, et al. Time to Flare in Patients with New- Onset versus Relapsing Giant Cell Arteritis Treated with Tocilizumab or Placebo Plus Prednisone Tapering: 3- Year Results from a Randomized Controlled Phase 3 Trial . ACR/ARHP-2019 2019; abstr. 1838.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Stone J, Han J, Unizony S, Aringer M, Blockmans D, Brouwer E, et al. Maintained Bene? t in Health- Related Quality of Life of Patients with Giant Cell Arteritis Treated with Tocilizumab Plus Prednisone Tapering: Results from the Open- Label, Long- Term Extension of a Phase 3 Randomized Controlled Trial . ACR/ARHP-2019 2019; abstr. 2663.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Stone JH, Bao M, Han J, Aringer M, Blockmans D, Brouwer E, et al. Long-Term Outcome of Tocilizumab for Patients with Giant Cell Arteritis: Results from Part 2 of the Giacta Trial. EULAR-2019 2019; abstr. OP0140.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/index.cfm?view=2&c=a&item=2019OP0140 -
Stone J, Bao M, Han J, Aringer M, Blockmans D, Brouwer E, et al. Long- Term Outcome of Tocilizumab for Patients with Giant Cell Arteritis: Results from Part 2 of a Randomized Controlled Phase 3 Trial . ACR/ARHP-2019 2019; abstr. 0808.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Unizony S, Bao M, Han J, Luder Y, Sidiropoulos P, Pei J, et al. Risk Factors for Treatment Failure in Patients with Giant Cell Arteritis Treated with Tocilizumab plus Prednisone Versus Prednisone Alone. EULAR-2019 2019; abstr. FRI0261.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/index.cfm?c=a&view=2&item=2019FRI0261 -
Bao M, Mallalieu NL, Stone JH. Low Immunogenicity in Patients with Giant Cell Arteritis Treated with Tocilizumab: 3-Year Results from the Randomized Controlled Portion and Open-Label Follow-Up of a Phase 3 Trial. EULAR-2020 2020; abstr. THU0295.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/?view=2&c=a&item=2020THU0295 -
Mallalieu N, Bao M, Stone J. Pharmacokinetics and Pharmacodynamics of Tocilizumab in Combination with Prednisone Tapering in Patients with Giant Cell Arteritis: 3- Year Results from a Randomized Controlled Phase 3 Trial . ACR/ARHP-2019 2019; abstr. 2668.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Stone JH, Mallalieu NL, Bao M. Low Immunogenicity in Patients with Giant Cell Arteritis Treated with Tocilizumab: 3-Year Results from the Randomized Controlled Portion and the Open-Label Follow-Up of a Phase 3 Trial. ACR/ARP-2020 2020; abstr. 1924.
Available from: URL: https://acrabstracts.org/abstract/low-immunogenicity-in-patients-with-giant-cell-arteritis-treated-with-tocilizumab-3-year-results-from-the-randomized-controlled-portion-and-the-open-label-follow-up-of-a-phase-3-trial/ -
Unizony S, Bao M, Han J, Luder Y, Sidiropoulos P, Pei J, et al. Risk Factors for Treatment Failure in Patients with Giant Cell Arteritis Treated with Tocilizumab Plus Prednisone versus Prednisone Alone . ACR/ARHP-2019 2019; abstr. 1840.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Unizony SH, Bao M, Han J, Luder Y, Pavlov A, Stone JH. Treatment failure in giant cell arteritis. Ann-Rheum-Dis 2021;.
PubMed | CrossRef Fulltext -
Goercke MC, Loricera J, Pena DP, Aldasoro V, Castaneda S, Villa-Blanco I, et al. A Multicenter Series of Giant Cell Arteritis Patients from Clinical Practice in Treatmet with Tocilizumab Compared with Giacta Trial. ACR/ARHP-2018 2018; abstr. 2756.
Available from: URL: https://acrabstracts.org/abstract/a-multicenter-series-of-giant-cell-arteritis-patients-from-clinical-practice-in-treatmet-with-tocilizumab-compared-with-giacta-trial/ -
Spiera R, Unizony S, Bao M, Luder Y, Sidiropoulos P, Pei J, et al. Clinical Outcomes of Patients with Giant Cell Arteritis with Polymyalgia Symptoms Only vs Cranial Symptoms Only Treated with Tocilizumab or Placebo in the Giacta Trial. EULAR-2019 2019; abstr. FRI0262.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/index.cfm?c=a&view=2&item=2019FRI0262 -
Stone JH, Tuckwell K, Dimonaco S, Klearman M, Mallalieu NL, Aringer M, et al. Optimal Dose of Tocilizumab for the Treatment of Giant Cell Arteritis: Efficacy, Safety, and Exposure-Efficacy Analysis from Giacta. EULAR-2017 2017; abstr. OP0131.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=356869 -
Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Effects of Baseline Prednisone Dose on Remission and Disease Flare in Patients with Giant Cell Arteritis Treated with Tocilizumab in a Phase 3 Randomized Controlled Trial. ACR/ARHP-2018 2018; abstr. 2751.
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Spiera R, Unizony S, Bao M, Luder Y, Sidiropoulos P, Han J, et al. Clinical Outcomes of Patients with Giant Cell Arteritis with Polymyalgia Symptoms Only vs Cranial Symptoms Only Treated with Tocilizumab or Placebo in a Randomized Clinical Trial . ACR/ARHP-2019 2019; abstr. 1836.
Available from: URL: https://www.rheumatology.org/Annual-Meeting -
Strand V, Dimonaco S, Tuckwell K, Klearman M, Collinson N, Stone JH. Health-Related Quality of Life in Patients with Giant Cell Arteritis Treated with Tocilizumab in a Randomized Controlled Phase 3 Trial. ACR/ARHP-2017 2017; abstr. 892.
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Vegas-Revenga N, Loricera J, Mera A, Pampin EP, Castaneda S, Dominguez-Casas LC, et al. Comparison between Giacta Trial and a Multicenter Series of Giant Cell Arteritis Patients from Clinical Practice with Tocilizumab. ACR/ARHP-2017 2017; abstr. 816.
Available from: URL: http://acrabstracts.org/abstract/comparison-between-giacta-trial-and-a-multicenter-series-of-giant-cell-arteritis-patients-from-clinical-practice-with-tocilizumab/ -
Unizony S, Mohan S, Han J, Stone JH. Characteristics of Giant Cell Arteritis Flares after Successful Treatment with Tocilizumab: Results from the Long-Term Extension of a Randomized Controlled Phase 3 Trial. EULAR-2021 2021; abstr. POS0808.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/index.cfm?view=2&c=a&item=2021POS0808 -
Bellone M, Pradelli L, Recchia A, Gervasi A, Orfanos P. Cost-Utility Analysis of Tocilizumab in Combination with Corticosteroids for the Treatment of Giant Cell Arteritis in Italian Patients. EISPOR-2018 2018; abstr. PSY108.
Available from: URL: https://tools.ispor.org/ScientificPresentationsDatabase/Presentation/88298?pdfid=56672 -
Stone JH, Spotswood H, Unizony SH, Aringer M, Blockmans D, Brouwer E, et al. New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension. . Rheumatology 2021;.
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Roche. Phase III GiACTA study shows Roche's Actemra/RoActemra is superior to steroids alone in maintaining steroid-free remission for people with giant cell arteritis. Media-Rel 2016;.
Media Release -
Stone JH, Spotswood H, Unizony S, Aringer M, Blockmans D, Brouwer E, et al. Time to Flare and Glucocorticoid Exposure in Patients with New-Onset Versus Relapsing Giant Cell Arteritis Treated with Tocilizumab or Placebo plus Prednisone Tapering: 3-Year Results from a Randomized Controlled Phase 3 Trial. EULAR-2020 2020; abstr. OP0027.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/?c=a&view=2&item=2020OP0027 -
Genentech. Phase III Study Shows Genentechs Actemra(R) (tocilizumab) Maintained Steroid-Free Remission in People With Giant Cell Arteritis (GCA). Media-Rel 2016;.
Media Release -
Mohan S, Han J, Stone JH. Efficacy of Adjunctive Methotrexate in Patients with Giant Cell Arteritis Treated with Tocilizumab plus Prednisone Tapering: Subanalysis of the Giacta Trial. EULAR-2020 2020; abstr. FRI0220.
Available from: URL: http://scientific.sparx-ip.net/archiveeular/?c=a&view=2&item=2020FRI0220 -
Roche. Phase III study shows Roche's Actemra/RoActemra maintained steroid-free remission in people with Giant Cell Arteritis (GCA). Media-Rel 2016;.
Media Release -
Strand V, Dimonaco S, Tuckwell K, Klearman M, Collinson N, Stone JH, et al. Health-Related Quality of Life in Patients with Giant Cell Arteritis Treated with Tocilizumab in a Phase 3 Randomized Controlled Trial. EULAR-2018 2018; abstr. SAT0550.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=398718 -
Stone JH, Han J, Mohan SV. Efficacy of Adjunctive Methotrexate in Patients with Giant Cell Arteritis Treated with Tocilizumab Plus Prednisone Tapering: Subanalysis of a Phase 3 Trial. ACR/ARP-2020 2020; abstr. 1926.
Available from: URL: https://acrabstracts.org/abstract/efficacy-of-adjunctive-methotrexate-in-patients-with-giant-cell-arteritis-treated-with-tocilizumab-plus-prednisone-tapering-subanalysis-of-a-phase-3-trial/ -
Strand V, Dimonaco S, Tuckwell K, Klearman M, Collinson N, Stone JH. Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial. Arthritis-Res-Ther 2019;21(1):64.
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ClinicalTrials.gov: US National Institutes of Health - Results. Trial-Reg 2018;.
Available from: URL: https://clinicaltrials.gov/ -
Patel N, Fu X, zhang y, Stone J. Baseline Glucocorticoid Toxicity in the Treatment of Giant Cell Arteritis: A Post Hoc Analysis of the GiACTA Trial. ACR/ARP-2022 2022; abstr. 0460.
Available from: URL: https://acrabstracts.org/abstract/ -
Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Trial of Tocilizumab in Giant-Cell Arteritis. N-Engl-J-Med 2017;377(4):317-328.
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Tuckwell K, Collinson N, Klearman M, Dimonaco S, Stone JH, Investigators tG. Baseline Data on Patients in Giacta (Tocilizumab in Giant Cell Arteritis). EULAR-2015 2015; abstr. FRI0248.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=252696 -
Tuckwell K, Collinson N, Klearman M, Dimonaco S, Stone JH, on behalf of the GiACTA Investigators. Baseline Data on Patients Enrolled in a Randomized, Double-Blind Trial of Tocilizumab in Giant Cell Arteritis. ACR/ARHP-2015 2015; abstr. 1979.
Available from: URL: http://www.acrabstracts.org/abstract/baseline-data-on-patients-enrolled-in-a-randomized-double-blind-trial-of-tocilizumab-in-giant-cell-arteritis/ -
Mallalieu NL, Stone JH, Villiger P, Klearman M, Brockwell L, Dimonaco S, et al. A Comparison of Pk and Pd Outcomes of Tocilizumab in Giant Cell Arteritis after Sc and IV Dosing. EULAR-2018 2018; abstr. OP0237.
Available from: URL: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=398759 -
Ishai A, Brouwer E, Maldini C, Stone JH, Espigol-Frigole GF, Cid MC, et al. Pet/Ct in Patients with Giant Cell Arteritis after 1 Year of Treatment with Tocilizumab plus Prednisone Taper or Only Prednisone Taper. EULAR-2018 2018; abstr. FRI0493.
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Stone JH, Han J, Unizony S, Aringer M, Blockmans D, Brouwer E, et al. Maintained Benefit in Health-Related Quality of Life of Patients with Giant Cell Arteritis Treated with Tocilizumab plus Prednisone Tapering: Results from the Open-Label, Long-Term Extension of a Phase 3 Randomized Controlled Trial. EULAR-2020 2020; abstr. SAT0275.
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Patel NJ, Tozzo V, Higgins JM, Stone JH. The effects of daily prednisone and tocilizumab on hemoglobin A1c during the treatment of giant cell arteritis. Arthritis-Rheumatol 2022;.
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Unizony S, Mohan SV, Han J, Stone JH. Characteristics of Giant Cell Arteritis Flares After Successful Treatment with Tocilizumab: Results from the Long-Term Extension of a Randomized Controlled Phase 3 Trial. ACR/ARP-2020 2020; abstr. 0516.
Available from: URL: https://acrabstracts.org/abstract -
Khanna D, Lin CJF, Furst DE, Wagner B, Zucchetto M, Raghu G, et al. Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open Label Extension of a Phase 3 Randomized Controlled Trial. . Am-J-Respir-Crit-Care-Med 2021;.
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Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche |
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Trial Information Support Line-TISL
Grenzacherstrasse 124 Basel Postcode: 4070 Switzerland global.rochegenentechtrials@roche.com |
F. Hoffmann-La Roche Ltd | Switzerland |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| A.O. Universitaria Pisana; Psichiatria | Pisa, Toscana | Italy |
| Aberdeen Royal Infirmary; Medical Oncology Dept | Aberdeen | United-Kingdom |
| Akademisch Ziekenhuis St. Radboud; Rheumatology | Nijmegen | Netherlands |
| Akademiska Sjukhuset; Lungmedicinska Kliniken | Uppsala | Sweden |
| Arcispedale Santa Maria Nuova; Reumatologia | Reggio Emilia, Emilia-Romagna | Italy |
| Arizona Arthritis & Rheumatology Research, Pllc | Paradise Valley, Arizona | USA |
| Arthritis Center of North Georgia | Gainesville, Georgia | USA |
| Asheville Arthritis & Osteoporosis Center, PA | Asheville, North Carolina | USA |
| Asklepios Klinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie | Bad Abbach | Germany |
| Azienda Ospedaliera di Padova; Cattedra e Divisione di Reumatologia | Padova, Veneto | Italy |
| Azienda Ospedaliera di Verona-Ospedale Civile Maggiore | Verona, Veneto | Italy |
| Azienda Ospedaliera Universitaria Careggi | Firenze, Toscana | Italy |
| Barnsley General Hospital; Rheumatology | Barnsley | United-Kingdom |
| Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie | Berlin | Germany |
| Cedars-Sinai Medical Center | Los Angeles, California | USA |
| CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease | Leeds | United-Kingdom |
| CHU Sart-Tilman | Liège | Belgium |
| Cividino Medicine Professional Corporation | Hamilton, Ontario | Canada |
| Clin Univ de Bxl Hôpital Erasme | Bruxelles | Belgium |
| Clin. de Rhumatologie | Trois-rivieres, Quebec | Canada |
| Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit | Colchester, Essex | United-Kingdom |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Reumatologia | Santiago de Compostela, La Coruña | Spain |
|
F. Hoffmann-La Roche Ltd
global.rochegenentechtrials@roche.com
show details
|
Basel | Switzerland |
| Four Rivers Clinical Research Inc. | Paducah, Kentucky | USA |
| Freeman Hospital; Dept of Rheumatology | Newcastle Upon Tyne | United-Kingdom |
| Førde sentralsjukehus | Førde | Norway |
| Haywood Hospital; Staffordshire Rheumatology Centre | Stoke-on-trent | United-Kingdom |
| Heartland Research Associates | Wichita, Kansas | USA |
| Hoffmann-La Roche |
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| Hopital Avicenne; Medecine Interne H5 | Bobigny | France |
| Hopital Claude Huriez; Internal Medicine | Lille | France |
| Hopital Cochin; Medecine Interne | Paris | France |
| Hopital Emile Muller; Medecine Interne | Mulhouse | France |
| Hopital Jean Verdier; Medecine Interne | Bondy | France |
| Hopital La Cavale Blanche; Rhumatologie | Brest | France |
| Hopital Saint Antoine; Oncologie Medicale | Paris | France |
| Hospital de Basurto; Servicio de Reumatologia | Bilbao, Vizcaya | Spain |
| Hospital For Special Surgery; Dept of Medicine - Rheumatology | New York, New York | USA |
| Hospital Geral de Santo Antonio; Servico de Imunologia Clinica | Porto | Portugal |
| Hospital Univ A Coruna; Rheumatology | A Coruna, La Coruña | Spain |
| Hospital Universitari de Bellvitge; Servicio de Reumatologia | Barcelona | Spain |
| Hospital Universitario de Canarias;servicio de Reumatologia | La Laguna, Tenerife | Spain |
| Hôpital de la Conception | Marseille | France |
| Instituto Portugues de Reumatologia | Lisboa | Portugal |
| Ipswich Hosital; Rheumatology Department | Ipswich | United-Kingdom |
| Irccs Policlinico San Matteo; Reumatologia Adulti | Pavia, Lombardia | Italy |
| Irccs San Raffele; Div Med Gen Immunologia Clinica | Milano, Lombardia | Italy |
| Karolinska Sjukhuset; Reumatologkliniken D2-1 | Stockholm | Sweden |
| Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II Rheumatologie | Frankfurt | Germany |
| Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1 | Szczecin | Poland |
| Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV | Munchen | Germany |
| Kreiskliniken Esslingen gGmbH Klinik Plochingen Medizinische Klinik | Plochingen | Germany |
| Lovelace Scientific Resources Inc. | Austin, Texas | USA |
| Marshfield Clinic Wausau Ctr | Wausau, Wisconsin | USA |
| Massachusetts General Hospital | Boston, Massachusetts | USA |
| Mayo Clinic Rochester | Rochester, Minnesota | USA |
| Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie | Hannover | Germany |
| Medizinische Universitat Graz | Graz | Austria |
| Moorfields Eye Hospital NHS Foundation Trust | London | United-Kingdom |
| Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease | Toronto, Ontario | Canada |
| Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731 | Hillerod | Denmark |
| NS-LIJ Health Systems; Rheum-Allergy Clin Immu | Lake Success, New York | USA |
| NYU Langone Medical Center; Seligman Center for Advanced Therapeutics | New York, New York | USA |
| Odense Universitetshospital | Odense C | Denmark |
| Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices | Birmingham | United-Kingdom |
| Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia | Udine, Friuli-Venezia Giulia | Italy |
| Presidio Ospedaliero Misericordia E Dolce; Divisione Medicina 2 - Dh Reumatologia | Prato, Toscana | Italy |
| Queen's Hospital | Romford | United-Kingdom |
| Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie | Bad Bramstedt | Germany |
| Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie | Baden-Baden | Germany |
| Rheumatic Disease Clin Res Ctr | Houston, Texas | USA |
| Rheumatology Assoc. of S. Florida - Clinical Research Center | Boca Raton, Florida | USA |
| Rheumatology Associates | Portland, Maine | USA |
| Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie | Herne | Germany |
| Rikshospitalet; Revmatologisk Avd Seksjon Barnerevmatologi | Oslo | Norway |
| Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie | Stuttgart | Germany |
|
Roche
www.roche.com/about_roche/roche_worldwide.htm
show details
Phone: 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com |
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| Royal Cornwall Hospital; Rhuematololgy Dept | Truro | United-Kingdom |
| Rush University Medical Center | Chicago, Illinois | USA |
| Sahlgrenska Universitetssjukhuset | Goteborg | Sweden |
| Sarasota Arthritis Res Center | Sarasota, Florida | USA |
| Schlosspark Klinik; Abt. Rheumatologie | Berlin | Germany |
| Shores Rheumatology | St. Claire Shores, Michigan | USA |
| Skånes Universitetssjukhus Malmö; Reumatologkliniken | Malmo | Sweden |
| Skånes Universitetssjukhus, Lund | Lund | Sweden |
| Southend Hospital; Rheumatology Department | Westcliffe-on-Sea, Essex | United-Kingdom |
| St. Olavs Hospital | Trondheim | Norway |
| Szpital Uniwersytecki; nr 2 im. Dr J. Biziela | Bydgoszcz | Poland |
| Sørlandet Sykehus Kristiansand | Kristiansand | Norway |
| The Vancouver Clinic | Vancouver, Washington | USA |
| Univ of Calif., Los Angeles; Rheumatology | Los Angeles, California | USA |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands |
| University of Barcelona; Dept. of Internal Medicine, | Barcelona | Spain |
| University of Edinburgh; The Queens Medical Research Institute | Edinburgh | United-Kingdom |
| University of Minnesota | Minneapolis, Minnesota | USA |
| University of Pennsylvania | Philadelphia, Pennsylvania | USA |
| University of South Florida School of Medicine Morsani Center for Advanced Health Care | Tampa, Florida | USA |
| University of Utah; Division of Rheumatology | Salt Lake City, Utah | USA |
| Università Degli Studi Di Genova - Dimi; Reumatologia | Genova, Liguria | Italy |
| Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III | Dresden | Germany |
| Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie | Erlangen | Germany |
| Universitätsklinikum Freiburg | Freiburg | Germany |
| Universitätsklinikum Jena; Klinik für Innere Medizin III | Jena | Germany |
| Universitätsklinikum S.-H. Campus Kiel; Klinik für Diagnostische Radiologie | Kiel | Germany |
| Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II | Tübingen | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie | Mainz | Germany |
| UZ Leuven Gasthuisberg | Leuven | Belgium |
| VU Medisch Centrum; Reumatologie 4-A-A2 | Amsterdam | Netherlands |
| Whytemans Brae Hospital; Rheumatology | Kirkcaldy | United-Kingdom |
| Ziekenhuis Rijnstate | Arnhem | Netherlands |
| Ziekenhuisgroep Twente, Hengelo | Hengelo | Netherlands |
| Ålesund sjukehus | Ålesund | Norway |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 30 Jan 2023 | Other trial event | Last checked against the European Clinical Trials Database record. Updated 30 Jan 2023 |
| 16 Nov 2022 | Results | Results evaluating longitudinal effects of both glucocorticoids (GCs) and tocilizumab, on hemoglobin A1c (HbA1c) during GC tapering, published in the Arthritis and Rheumatology Updated 21 Nov 2022 |
| 14 Nov 2022 | Results | Results of post-hoc analysis assessing glucocorticoid toxicity in the treatment of giant cell arteritis, presented at the ACR Convergence 2022. Updated 30 Dec 2022 |
| 01 Dec 2021 | Results | Results published in the American Journal of Respiratory and Critical Care Medicine. Updated 06 Dec 2021 |
| 29 Oct 2021 | Results | 3-year results from a randomized controlled trial and extension published in the Rheumatology Updated 09 Nov 2021 |
| 05 Jun 2021 | Results | Results of an analysis investigating disease flare characteristics after successful treatment with TCZ in GiACTA presented at the 22nd Annual Congress of the European League Against Rheumatism Updated 20 Jun 2021 |
| 28 May 2021 | Results | Results of post-hoc analysis of risk factors for treatment failure in giant cell arteritis treatment with tocilizumab in combination with glucocorticoids, published in the Annals of the Rheumatic Diseases. Updated 04 Jun 2021 |
| 09 Nov 2020 | Results | Results of post-hoc analysis data from part 2 of this study was 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 presented at the 84th American College of Rheumatology and the 55th Association of Rheumatology Health Professionals Updated 12 Jan 2021 |
| 09 Nov 2020 | Results | Results of a sub-analysis assessing the efficacy and safety in patients who received adjunctive Methotrexate presented at the 84th American College of Rheumatology and the 55th Association of Rheumatology Health Professionals Updated 04 Jan 2021 |
| 06 Jun 2020 | Results | Results assessing immunogenicity in patients with giant cell arteritis treated with tocilizumab, presented at the 21st Annual Congress of the European League Against Rheumatism. Updated 30 Jun 2020 |
| 06 Jun 2020 | Results | Results presented at the 21st Annual Congress of the European League Against Rheumatism Updated 28 Jun 2020 |
| 06 Jun 2020 | Results | Results of this post-hoc analysis assessing the efficacy of adjunctive MTX in patients with GCA presented at the 21st Annual Congress of the European League Against Rheumatism Updated 27 Jun 2020 |
| 06 Jun 2020 | Results | Results presented at the 21st Annual Congress of the European League Against Rheumatism Updated 27 Jun 2020 |
| 10 Feb 2020 | Other trial event | Last checked against the ClinicalTrials.gov record. Updated 10 Feb 2020 |
| 06 Feb 2020 | Biomarker Update | Biomarkers information updated Updated 06 Nov 2021 |
| 13 Nov 2019 | Results | Results 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 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 | 3 year results presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 07 Feb 2020 |
| 13 Nov 2019 | Results | Results of apost hoc analysis presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 07 Feb 2020 |
| 13 Nov 2019 | Results | Results presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 07 Feb 2020 |
| 13 Nov 2019 | Results | Results (n=215) assessing long-term safety and efficacy in 2-year long-term extension (part 2) of this trial, presented at the 83rd American College of Rheumatology and the 54th Association of Rheumatology Health Professionals Annual Scientific Meeting. Updated 06 Feb 2020 |
| 15 Jun 2019 | Results | Results identifying predictors of treatment failure in Giant Cell Arteritis patients receiving tocilizumab (TCZ) or placebo (PBO) in combination with prednisone presented at the 20th Annual Congress of the European League Against Rheumatism Updated 23 Jun 2019 |
| 15 Jun 2019 | Results | Results determining long term safety and exploring maintenance of efficacy in Giant Cell Arteritis patients in a 2-year long-term extension (part 2) of this trial presented at the 20th Annual Congress of the European League Against Rheumatism Updated 23 Jun 2019 |
| 15 Jun 2019 | Results | Results assessing efficacy of Tocilizumab in patients with Giant cell arteritis with Polymyalgia symptoms only vs Cranial symptoms presented at the 20th Annual Congress of the European League Against Rheumatism Updated 23 Jun 2019 |
| 20 Feb 2019 | Results | Results published in the Arthritis Research and Therapy Updated 21 Apr 2020 |
| 02 Feb 2019 | Other trial event | This trial has been completed in UK - MHRA (End date: 2018-06-04). Updated 07 Feb 2019 |
| 30 Jan 2019 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 20 Feb 2019 |
| 14 Nov 2018 | Results | Cost-Utility analysis of Tocilizumab in Combination with Corticosteroids presented at the 21st Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research. Updated 05 Dec 2018 |
| 24 Oct 2018 | Results | Results of a post-hoc analysis assessing the effects of baseline Prednisone on remission and disease flare in patients with Giant cell Arteritis, presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 20 Nov 2018 |
| 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 19 Nov 2018 |
| 24 Jul 2018 | Other trial event | This trial has been completed in Poland (End date: 2018-06-04). Updated 26 Jul 2018 |
| 05 Jul 2018 | Other trial event | This trial has been completed in Spain (End date: 2018-06-04). Updated 12 Jul 2018 |
| 29 Jun 2018 | Other trial event | This trial has been completed in Germany (End date: 2018-06-04). Updated 03 Jul 2018 |
| 28 Jun 2018 | Other trial event | This trial has been completed in Netherlands. Updated 03 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 of subgroup analysis assessing degree of FDG uptake presented at the 19th Annual Congress of the European League Against Rheumatism. Updated 15 Jul 2018 |
| 16 Jun 2018 | Results | Results comparing PK and PD outcomes of Tocilizumab in giant cell artritis patients after subcutaneous and intravenous dosing by taking data from this and other randomised controlled study, presented at the 19th Annual Congress of the European League Against Rheumatism. Updated 14 Jul 2018 |
| 15 Jun 2018 | Other trial event | This trial has been completed in Sweden (end date: 2018-06-04) Updated 19 Jun 2018 |
| 09 Jun 2018 | Other trial event | This trial has been completed in Belgium (end date: 2018-06-04) Updated 12 Jun 2018 |
| 19 Dec 2017 | Results | Results published in the Annals of Internal Medicine Updated 03 Jan 2018 |
| 08 Nov 2017 | Results | Results of post hoc exploratory analysis assessing patient reported outcomes in patients treated with QW tocilizumab for 52 weeks presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 19 Dec 2017 |
| 08 Nov 2017 | Results | Results comparing GiACTA trial data from those of a national multicenter series of patients with GCA from the clinical practice, focusing on the baseline characteristics of the patients, were 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 of analysis assessing safety safety of tocilizumab in giant cell arteritis or rheumatoid arthritis patients from general healthcare claim database (see CTP 291318) and clinical development program presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting Updated 18 Dec 2017 |
| 02 Nov 2017 | Other trial event | According to a Roche media release, the Health Canada has approved ACTEMRA (tocilizumab) for the treatment of adult patients with giant cell arteritis (GCA). The approval was based on results of this trial. Updated 09 Nov 2017 |
| 25 Oct 2017 | Other trial event | This trial has been completed in Denmark. Updated 27 Oct 2017 |
| 22 Sep 2017 | Other trial event | According to a Roche media release, Actemra/RoActemra was approved for the treatment of giant cell arteritis by New Zealand's Medsafe in May 2017. Updated 29 Sep 2017 |
| 22 Sep 2017 | Other trial event | According to a Roche media release, the European Commission (EC) has approved Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis. The approval is based on data from this trial. Updated 29 Sep 2017 |
| 25 Aug 2017 | Other trial event | According to a Chugai Pharmaceuticals media release, based on the results from this and MRA632JP study, the company obtained an approval Actemra 162mg Syringe for subcutaneous (SC) Injection and Actemra 162mg Auto-Injector for SC Injection by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional indications of Takayasu arteritis (TAK) and giant cell arteritis (GCA) that have not responded sufficiently to existing therapies. Updated 29 Aug 2017 |
| 27 Jul 2017 | Results | Results published in the New England Journal of Medicine Updated 31 Jul 2017 |
| 26 Jul 2017 | Results | Results published in a Genentech Media Release. Updated 28 Jul 2017 |
| 26 Jul 2017 | Endpoint met | Primary endpoint has been met. (Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper), according to a Genentech media release. Updated 28 Jul 2017 |
| 26 Jul 2017 | Results | According to a Genentech media release, data from this trial were published in the July 27, 2017 issue of the New England Journal of Medicine. Updated 28 Jul 2017 |
| 21 Jul 2017 | Other trial event | According to a Roche Pharmaceutical media release, based on the results from this study, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra , RoActemra (tocilizumab) for the treatment of giant cell arteritis (GCA). Updated 26 Jul 2017 |
| 17 Jun 2017 | Results | Results presented at the 18th Annual Congress of the European League Against Rheumatism Updated 06 Jul 2017 |
| 22 May 2017 | Other trial event | According to a Food and Drug Administration media release, the FDA today approved the use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. Updated 29 May 2017 |
| 18 May 2017 | Results | Results published in the ClinicalTrials.gov Trial Registry Updated 26 Mar 2020 |
| 24 Jan 2017 | Other trial event | According to a Genentech media release, the U.S. Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application (sBLA) and granted Priority Review Designation for Actemra for the treatment of GCA. Updated 25 Jan 2017 |
| 30 Nov 2016 | Results | According to a Chugai Pharmaceutical media release, results from this study were presented at the American College of Rheumatology (ACR) conference on November 13 2016, and at the Association for Rheumatology Health Professionals (ARHP) annual meeting. Updated 09 Dec 2016 |
| 30 Nov 2016 | Other trial event | According to a Chugai Pharmaceutical media release, based on the results from this and MRA632JP study, the company has filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication of large vessel vasculitis (LVV) for the humanized anti-human IL-6 receptor monoclonal antibody, Actemra. Updated 09 Dec 2016 |
| 16 Nov 2016 | Results | Results from 52-weeks of analysis presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals. Updated 30 Jan 2017 |
| 12 Nov 2016 | Results | Results published in the Roche Media Release Updated 05 Dec 2016 |
| 12 Nov 2016 | Other trial event | According to a Genentech media release, results from this trial will be submitted to regulatory authorities around the world, including the U.S. Food and Drug Administration (FDA), by the end of 2016 Updated 24 Nov 2016 |
| 12 Nov 2016 | Results | Results published in the Genentech Media Release Updated 24 Nov 2016 |
| 02 Nov 2016 | Other trial event | Results will be presented at the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting, according to a Genentech media release. Updated 14 Nov 2016 |
| 05 Oct 2016 | Other trial event | According to Genentech media release, full data will be presented at an upcoming medical meeting in 2016. Updated 22 Oct 2016 |
| 05 Oct 2016 | Other trial event | According to Chugai Pharmaceutical media release, FDA has granted Breakthrough Therapy Designation to ACTEMRA/RoACTEMRA for Giant Cell Arteritis. Updated 17 Oct 2016 |
| 06 Jun 2016 | Other trial event | According to a Genentech media release data from this trial will be submitted to FDA for approval consideration. Updated 09 Jun 2016 |
| 06 Jun 2016 | Results | Results published in a Genentech media release. Updated 09 Jun 2016 |
| 06 Jun 2016 | Other trial event | According to a Roche media release, the results from this trial will support regulatory submissions. Data from this trial will be submitted for presentation at an upcoming medical conference. Updated 07 Jun 2016 |
| 06 Jun 2016 | Results | Results published in a Roche media release. Updated 07 Jun 2016 |
| 11 Nov 2015 | Results | Results assessing baseline data (n=241) presented at the 79th American College of Rheumatology and the 50th Annual Meeting of the Association of Rheumatology and Health Professionals Updated 02 Feb 2016 |
| 02 Nov 2015 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record. Updated 05 Nov 2015 |
| 13 Jun 2015 | Other trial event | According to an abstract presented at the 16th Annual Congress of the European League Against Rheumatism, 200 patients have been enrolled till date. Updated 27 Jul 2015 |
| 13 Jun 2015 | Results | Results assessing baseline data (n=200) presented at the 16th Annual Congress of the European League Against Rheumatism. Updated 27 Jul 2015 |
| 11 May 2015 | Completion date | According to the ClinicalTrials.gov record, planned end date changed from 1 Jun 2018 to 1 Apr 2018. Updated 20 May 2015 |
| 11 May 2015 | Other trial event | According to the ClinicalTrials.gov record, planned primary completion date changed from 1 Jun 2018 to 1 Apr 2018. Updated 20 May 2015 |
| 26 Jan 2015 | Completion date | Planned End Date changed from 1 Nov 2017 to 1 Jun 2018 as reported by ClinicalTrials.gov Updated 04 Feb 2015 |
| 26 Jan 2015 | Other trial event | Planned primary completion date changed from 1 Nov 2017 to 1 Jun 2018 as reported by ClinicalTrials.gov. Updated 04 Feb 2015 |
| 12 Jan 2015 | Completion date | Planned End Date changed from 1 Jun 2018 to 1 Nov 2017 as reported by ClinicalTrials.gov Updated 16 Jan 2015 |
| 12 Jan 2015 | Other trial event | Planned primary completion date changed from 1 Jun 2018 to 1 Nov 2017 as reported by ClinicalTrials.gov. Updated 16 Jan 2015 |
| 23 Dec 2014 | Completion date | Planned End Date changed from 1 Nov 2017 to 1 Jun 2018 according to ClinicalTrials.gov record Updated 31 Dec 2014 |
| 23 Dec 2014 | Other trial event | Planned primary completion date changed from 1 Nov 2017 to 1 Jun 2018 according to ClinicalTrials.gov record. Updated 31 Dec 2014 |
| 15 Dec 2014 | Completion date | Planned End Date changed from 1 Jun 2018 to 1 Nov 2017, as per ClinicalTrials.gov record. Updated 18 Dec 2014 |
| 15 Dec 2014 | Other trial event | Planned primary completion date changed from 1 Jun 2018 to 1 Nov 2017, as per ClinicalTrials.gov record. Updated 18 Dec 2014 |
| 08 Dec 2014 | Completion date | Planned End Date changed from 1 Nov 2017 to 1 Jun 2018, as per ClinicalTrials.gov record. Updated 18 Dec 2014 |
| 08 Dec 2014 | Other trial event | Planned primary completion date changed from 1 Nov 2017 to 1 Jun 2018, as per ClinicalTrials.gov record. Updated 18 Dec 2014 |
| 24 Nov 2014 | Completion date | Planned End Date changed from 1 Jun 2018 to 1 Nov 2017, as per ClinicalTrials.gov record. Updated 18 Dec 2014 |
| 24 Nov 2014 | Other trial event | Planned primary completion date changed from 1 Jun 2018 to 1 Nov 2017, as per ClinicalTrials.gov record. Updated 18 Dec 2014 |
| 03 Nov 2014 | Completion date | According to the ClinicalTrials.gov record, planned end date changed from 1 Nov 2017 to 1 Jun 2018. Updated 20 Nov 2014 |
| 31 Jul 2014 | Other trial event | New source identified and integrated (European Clinical Trials Database; EudraCT2011-006022-25). Updated 31 Jul 2014 |
| 24 Jun 2014 | New trial record | New trial record Updated 24 Jun 2014 |
| 23 Jul 2013 | Status change - recruiting | Updated 24 Jun 2014 |
Table of Contents
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