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 Rheumatoid Arthritis Despite Methotrexate Therapy

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment444% Female81%% White77%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T06Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)51

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

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.