|Clinical Trial Title
|A multicenter, open-label study to assess the pharmacokinetics, safety, and efficacy of certolizumab pegol in children and adolescents with moderately to severely active polyarticular-course juvenile idiopathic arthritis (PASCAL)
|Closed to Enrollment
|Juvenile Idiopathic Arthritis
The overall study consists of a Screening Period of up to 4 weeks and an Open-Label Treatment Period which will continue until the approval of the marketing application for the Polyarticular-course Juvenile Idiopathic Arthritis (JIA) indication in the subject's country or region or until further notice from UCB (approximately 3-5 years duration; depending on region). A Final Visit will be conducted 12 weeks after last dose of study medication. Overall, study visits will occur monthly during the first 6 months and every 2 months afterwards. All patients will receive active treatment with Certolizumab Pegol. The dose will depend on actual weight. Home dosing will be allowed between study visits.
Diagnosis of Polyarticular-course Juvenile Idiopathic Arthritis (JIA) for at least 6 months prior to Baseline (Active Polyarticular-course JIA disease is defined as ≥ 5 joints with active Arthritis including: Polyarticular Rheumatoid Factor (RF)-positive, Polyarticular RF-negative, extended oligoarticular, Juvenile Psoriatic Arthritis and enthesitis-related Arthritis)
Children and adolescents, aged 2 to 17 years (inclusive); weight ≥ 10 kg
Inadequate response or intolerance to at least 1 Disease-Modifying Antirheumatic Drug (DMARD) (previous exposure to a maximum of 2 biologic agents will be allowed)
Methotrexate (MTX) and oral Corticosteroids will be allowed at stable doses prior to Screening
Inadequate response or intolerance to Methotrexate (MTX)
Enrollment status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
|Daniel Kingsbury, MD