Study Phase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Trial Information

Generic NameSirukumabProduct NamePLIVENSIATherapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupInterleukin InhibitorsCondition StudiedArthritis, Rheumatoid
Sponsor Protocol NumberCNTO136ARA3003Enrollment878Data PartnerJohnson & Johnson% Female81.1%Mean/Median Age (Years)55.4% White75.3%

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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