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 (JIA)
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 (JIA).
If less than 50 % of the study population achieves an adequate response to the treatment (American College of Rheumatology Pediatric 30 % (PedACR30) response) at Week 16, the study will be entirely discontinued.
2 Years to 17 Years
Accepting Healthy Volunteers?
- Onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment 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
- If not using Methotrexate (MTX), inadequate response or intolerance to MTX
- History of systemic JIA, with or without systemic features
- Active Uveitis or a history of active Uveitis within the preceding 6 months
- Known history of Tuberculosis (TB), or high risk of acquiring TB and latent TB infection; chronic, recurrent infection current sign or symptom which may indicate infection, or at high risk of infection
- Viral Hepatitis or Human Immunodeficiency Virus (HIV) infection; live vaccination, including attenuated, within defined period prior to study entry or during the study (non-live vaccinations are permitted at any time prior to and during the study)
- The use of, or dose changes to, specific medications (eg, non-biologic DMARDs, biologic DMARDs, oral and intramuscular/intravenous/intra-articular Corticosteroids) will not be allowed for defined periods of time prior to study entry
- Previous exposure to Certolizumab Pegol (CZP), to more than 2 biologic DMARDs and previous lack of response to more than 1 Tumor Necrosis Factor (TNFα) antagonist drug