Status:
TERMINATED
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)
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Schering-Plough
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief 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 tha...
Detailed Description
Approximately 170 juvenile patients will take part in the study worldwide. All patients will receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab subcutaneously (injection...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01230827
Start Date
December 1 2010
End Date
May 1 2014
Last Update
April 4 2016
Active Locations (35)
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1
Los Angeles, California, United States
2
San Francisco, California, United States
3
Augusta, Georgia, United States
4
Boston, Massachusetts, United States