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Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

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Trial Profile

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms ORAL-Step
  • Sponsors Pfizer

    • Most Recent Events

    • 15 Jun 2019 Results of a post-hoc analysis of ORAL Step, ORAL Scan, ORAL Sync, ORAL Standard, ORAL Solo and ORAL Strategy assessing the frequency and duration of the most common tolerability-related non-serious AEs in patients with RA receiving tofacitinib 5 mg BID (n=2657) presented at the 20th Annual Congress of the European League Against Rheumatism
    • 24 Oct 2018 Results of pooled data Phase 3 and Phase 3b/4 studies (ORAL Step (NCT00960440); ORAL Solo (NCT00814307); ORAL Scan (NCT00847613); ORAL Sync (NCT00856544); ORAL Standard (NCT00853385); and ORAL Strategy (NCT02187055)) describing the frequency and duration of the most commonly reported non serious AEs related to tolerability, presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
    • 16 Jun 2018 Results of pooled data from 4 Phase 2 trials (NCT00413660; NCT00550446; NCT00603512; NCT00687193) and 5 Phase 3 randomised, double-blind, placebo-controlled trials (ORAL Scan [NCT00847613]; ORAL Solo [NCT00814307]; ORAL Sync [NCT00856544]; ORAL Standard [NCT00853385]; ORAL Step [NCT00960440]), were presented at the 19th Annual Congress of the European League Against Rheumatism.

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