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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History