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A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

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Trial Profile

A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2021

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At a glance

  • Drugs Methotrexate (Primary) ; Methotrexate (Primary) ; Rituximab (Primary) ; Folic acid; Methylprednisolone
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms IMAGE
  • Sponsors Genentech; Roche
  • Most Recent Events

    • 10 Nov 2012 Planned number of patients changed from 750 to 853.
    • 09 Aug 2011 Status changed from active, no longer recruiting to completed.
    • 19 Jun 2010 Two-year results were presented at the 11th Annual Congress of the European League Against Rheumatism.
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