A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Juvenile Idiopathic Arthritis

In brief

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

Key facts

Study ID

NCT01230827

Run by

Janssen Research & Development, LLC

People needed

173

Starts

2010-12-01

Expected to finish

2014-05-01

Last updated by the study team

2016-04-04

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis must have been before the patient's 16th birthday
• Disease duration of at least 6 months before study entry
• Must have 5 or more joints with active arthritis
• Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
• May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
• Must have qualifying laboratory values at the first visit.

You may not qualify if…

• Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
• Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
• Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Augusta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Bregenz, Austria
• Study site — Vienna, Austria
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Botucatu, Brazil
• Study site — Curitiba, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Halifax, Nova Scotia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Helsinki, Finland
• Study site — Oulu, Finland
• Study site — Bad Bramstedt, Germany
• Study site — Berlin, Germany
• Study site — Bremen, Germany
• Study site — Hamburg, Germany
• Study site — Sankt Augustin, Germany

Full record on ClinicalTrials.gov

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