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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

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

    • 17 Jun 2017 Result of pooled post-hoc analysis from six phase III studies including this study presented at the 18th Annual Congress of the European League Against Rheumatism
    • 10 Jun 2017 Biomarkers information updated
    • 27 Mar 2017 According to a Pfizer media release, based on the phase 3 Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data the European Commission (EC) has approved XELJANZ (tofacitinib citrate) 5 mg twice daily oral tablets in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top