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)
Juvenile Idiopathic Arthritis
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile Idiopathic Arthritis, golimumab, juvenile arthritis, GO KIDS, anti TNF alpha medications, juvenile psoriatic arthritis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
CNTO 148 (Golimumab)
Placebo
All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response at Week 16 and who are randomly allocated to golimumab, will receive 30 mg per square meter every 4 weeks through Week 48. Patients will continue to receive golimumab 30 mg per square meter after Week 48 in a long-term extension until Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration.
All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive placebo every 4 weeks through Week 48. However, patients receiving placebo and who will have lack/loss of clinical response will be eligible to receive golimumab 30 mg per square meter every 4 weeks through Week 48. At Week 48, patients do not have a clinical response will begin to receive golimumab 30 mg per square meter in a long-term extension until Week 248 and patients who have a clinical response will be discontinued from the study. All patients will receive their fixed dose of commercial methotrexate throughout the study duration.