Pediatric Arthritis Study of Certolizumab Pegol

  • Interventional
  • Recruiting
  • NCT01550003
Eligibility Details Visit Clinicaltrials.gov

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).

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 4-6 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.

     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.

Gender
All

Age Group
2 Years to 17 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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

        Exclusion Criteria:

         - 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
  • Arthritis

At a Glance

National Government IDNCT01550003

IRB#IRB12-1401

Lead SponsorUCB BIOSCIENCES GmbH

Lead PhysicianLinda Wagner-Weiner

Collaborator(s)N/A

EligibilityAll
2 Years to 17 Years
Recruiting