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Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

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Trial Profile

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Oct 2023

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At a glance

  • Drugs Tofacitinib (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ORAL-Start
  • Sponsors Pfizer

Most Recent Events

  • 29 Sep 2023 Results of post hoc analyses characterizing joint-specific responses to tofacitinib and methotrexate monotherapy in patients with RA, published in the Arthritis Research and Therapy
  • 09 Nov 2021 Results of post hoc analyses from RCT data: Cohort C, (NCT00814307, NCT02187055); C2, (NCT01039688); and C3, (NCT00413699, NCT00661661) assessing the patient characteristics, efficacy, and treatment patterns for tofacitinib monotherapy in patient with rheumatoid arthritis using RCT data and available RWD, presented at the ACR Convergence 2021.
  • 15 Jun 2019 Results of post hoc pooled analysis evaluating whether treatment of RA with tofacitinib + MTX or GC suppresses IFN pathway proteins to a greater extent than treatment with tofacitinib monotherapy (NCT00687193, NCT00847613, NCT01039688) presented at the 20th Annual Congress of the European League Against Rheumatism

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