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

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-Naive Patients With Rheumatoid Arthritis

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

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