Study Phase 3

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF Alpha Naive Subjects With Active Radiographic Axial Spondyloarthritis

Trial Information

Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment347% Female15%% White72.8%
Product ClassmAB anti-IL12 and anti-IL23Sponsor Protocol NumberCNTO1275AKS3001Data PartnerJohnson & JohnsonCondition StudiedAxial SpondyloarthritisMean/Median Age (Years)39

Supporting Documentation

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

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