Study Phase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupTumor Necrosis Factor Alpha (TNF-α) InhibitorsCondition StudiedArthritis, Rheumatoid
Sponsor Protocol NumberC0524T05Enrollment637Data PartnerJohnson & Johnson% Female82.9%Mean/Median Age (Years)50.0% White72.4%

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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