Juvenile Idiopathic Arthritis
Conditions
Interventions
Trade Name: Cimzia
Pharmaceutical Form: Solution for injection
INN or Proposed INN: certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Other descriptive name: Certolizumab pegol
C
Sponsors
UCB BIOSCIENCES GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2) - Study participants must weigh =10 kg (22lb) at Baseline (Visit 2) - Study participants must have had 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 (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA) - Study participants must have active polyarticular-course disease, defined as =5 joints with active arthritis at Screening and at Baseline - Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator’s clinical judgment) - If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at =10 to =15 mg/m^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response - If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose Are the trial subjects under 18? yes Number of subjects for this age range: 193 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Study participant has previously been exposed to more than 2 biologic agents - Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFa) antagonist drug - Study participant is currently receiving or has received any experimental (biological or non-biological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer - Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction - Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not) - Study participant has a history of systemic JIA, with or without systemic features. - Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study medication - Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related) - Study participant has active uveitis or a history of active uveitis within the preceding 6 months - Study participant has current, chronic or recurrent clinically significant infections - Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator’s opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the Pharmacokinetic (PK) and safety including the immunogenicity of certolizumab pegol (CZP) administered subcutaneously (sc) in children and adolescents with moderate to severe polyarticular-course juvenile idiopathic arthritis (JIA);Secondary Objective: Assess the effectiveness of CZP on the clinical response in children and adolescents with moderate to severe polyarticular-course JIA;Primary end point(s): 1. Certolizumab Pegol (CZP) Plasma Concentration level at Week 16 2. Certolizumab Pegol (CZP) Plasma Concentration level at Week 48 3. Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 16 4. Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 48 5. Incidence of serious treatment-emergent adverse events (TEAEs) during the study 6. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of the Investigational Medicinal Product (IMP) during the study;Timepoint(s) of evaluation of this end point: 1. Week 16 2. Week 48 3. Week 16 4. Week 48 5. From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP) 6. From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 7. American College of Rheumatology Pediatric 30 % (PedACR30) Response at Week 16 8. American College of Rheumatology Pediatric 50 % (PedACR50) Response at Week 16 9. American College of Rheumatology Pediatric 70 % (PedACR70) Response at Week 16 10. American College of Rheumatology Pediatric 90 % (PedACR90) Response at Week 16;Timepoint(s) of evaluation of this end point: 7. Week 16 8. Week 16 9. Week 16 10. Week 16 | — |
Countries
Argentina, Brazil, Canada, Chile, Mexico, Russian Federation, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed