Study Phase 3

A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

Trial Information

Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupTumor Necrosis Factor Alpha (TNF-α) InhibitorsCondition StudiedArthritis, Juvenile
Sponsor Protocol NumberCNTO148JIA3003Enrollment130Data PartnerJohnson & Johnson% Female73.2%Mean/Median Age (Years)11.6% White66.9%

Supporting Documentation

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

Additional primary citation found here: https://pubmed.ncbi.nlm.nih.gov/39089836/

Disclaimer

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