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)

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Schering-Plough
• Treatments: Antibodies, Monoclonal; Golimumab; Methotrexate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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