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PASCAL Study

Trial

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

May 2, 2012

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 Name

Daniel Kingsbury, MD

Contact Name

Kristin Hickey

Phone

(503) 413-5447

Contact E-Mail

khickey@lhs.org

Last Updated: Tuesday, March 20, 2018 03:15:51 PM