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A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Trial Profile

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jan 2022

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At a glance

  • Drugs Tofacitinib (Primary) ; Adalimumab
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 06 Jun 2020 Results (n=2180) of post hoc pooled analysis of P2 (A3921035; NCT00550446 [first 12-week randomised parallel treatment period only]), P3 (ORAL Standard; NCT00853385) and P3b/4 (ORAL Strategy; NCT02187055) studies, presented at the 21st Annual Congress of the European League Against Rheumatism
    • 12 Sep 2019 Results characterizing the relationship between tofacitinib dose and efficacy, as measured by American College of Rheumatology (ACR) response rates, and comparing this between Japanese and Western patients with RA using data from 2 double blind studies (NCT00687193 and NCT00550446) published in the Journal of Clinical Pharmacology
    • 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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