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A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06410293 And Adalimumab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

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A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06410293 And Adalimumab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Aug 2022

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms REFLECTIONS; REFLECTIONS B538-02
  • Sponsors Pfizer

    • Most Recent Events

    • 22 Aug 2022 New source identified and integrated Japan Pharmaceutical Information Center - Clinical Trials Information(JapicCTI153018).
    • 25 Mar 2022 According to a Pfizer media release, company anticipates submitting study results for presentation at an upcoming medical congress.
    • 25 Feb 2022 According to a Pfizer media release, the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022.

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