PASCAL
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) |
Trial Status | Closed to Enrollment |
Start Date | 05/02/2012 |
Location | randall-childrens-hospital-at-legacy-emanuel |
Trial Type | Pediatric Rheumatology |
Specific Condition | Juvenile Idiopathic Arthritis |
Description | 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. |
Eligibility Criteria | 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) |
IRB Number | 10594 |
Notes | 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. |
Principal Investigator | Daniel Kingsbury, MD |
Contact Name | Kristin Hickey |
Contact Phone | (503) 413-5447 |
Contact Fax | |
Contact E-Mail | khickey@lhs.org |