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 AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupInterleukin InhibitorsCondition StudiedAxial Spondyloarthritis
Sponsor Protocol NumberCNTO1275AKS3001Enrollment347Data PartnerJohnson & Johnson% Female15%Mean/Median Age (Years)39% White72.8%

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

Disclaimer

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