Summary

for people ages 2-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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).

Official 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 (JIA)

Details

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.

Keywords

Polyarticular-course Juvenile Idiopathic Arthritis (JIA) Cimzia JIA Polyarticular Oligoarticular Enthesitis-related-Arthritis Juvenile Idiopathic Arthritis Juvenile Psoriatic Arthritis Certolizumab Pegol PASCAL CDP870 Arthritis Arthritis, Juvenile Certolizumab Pegol (CZP)

Eligibility

You can join if…

Open to people ages 2-17

  • 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

You CAN'T join if...

  • 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

Locations

  • 84
    San Francisco California 94143 United States
  • 79
    Los Angeles California 90027-60 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UCB BIOSCIENCES GmbH
ID
NCT01550003
Phase
Phase 3
Study Type
Interventional
Last Updated