A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy

Trial Profile

A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy

Discontinued
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2016

At a glance

  • Drugs Golimumab (Primary) ; Methotrexate
  • Indications Juvenile rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms GO-KIDS
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 27 May 2016 According to a Janseen media release, the CHMP of the EMA has adopted a positive opinion, recommending the use of subcutaneous SIMPONI (golimumab) in combination with methotrexate (MTX) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX. Based on the CHMP's positive opinion, a final decision from the European Commission is expected in the coming months.
    • 27 May 2016 Results published in a Janssen media release.
    • 27 May 2016 Primary endpoint (Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Experienced a Flare of Disease) has not been met, according to a Janssen media release.
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