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 Ankylosing Spondylitis

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment356% Female28.4%% White73.6%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T09Data PartnerJohnson & JohnsonCondition StudiedSpondylitis, Ankylosing (Nonradiographic Axial)Mean/Median Age (Years)38.5

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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