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Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

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Trial Profile

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

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-Solo
  • Sponsors Pfizer

Most Recent Events

  • 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 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
  • 15 Jun 2019 Results of a pooled post-hoc analysis of NCT00550446, ORAL Solo and ORAL Strategy assessing the effect of tofacitinib monotherapy (n=676) presented at the 20th Annual Congress of the European League Against Rheumatism

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