Study Phase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti TNFa Agent(s)

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment461% Female80%% White87.4%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T11Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)54

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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