Juvenile Idiopathic Arthritis (JIA)
Conditions
Interventions
Experimental group: Up to 19 subjects are planned to be enrolled and treated in Brazil. Subjects will be administered Certolizumab Pegol (CZP) subcutaneously (sc
under the skin) as a fixed dose based on the subject´s weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. Eligible subjects will begin with 3 loading doses of CZP administered ove
Drug
E02.319
Sponsors
UCB BIOSCIENCES GmbH
UCB BIOSCIENCES GmbH
Hospital São Paulo
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Subjects must have had polyarticular juvenile idiopathic arthritis (JIA) for at least 6 months prior to baseline (polyarticular JIA is defined as more than or equal to 5 joints with active arthritis, including: polyarthritis rheumatoid factor positive, polyarthritis rheumatoid factor negative, extended oligoarthritis, psoriatic arthritis, juvenile arthritis and enthesitis-related arthritis (ERA)). The study population will consist of 2-17 year-old subjects in the inclusion with a minimum weight of 10 kg. Subjects must have had an inadequate response or intolerance to at least one disease modifying anti-rheumatic drug (DMARD). Methotrexate (MTX) and oral corticosteroids will be allowed at stable doses prior to Screening. If not using Methotrexate, subjects must have had an inadequate response or intolerance to Methotrexate (MTX).
Exclusion criteria
Exclusion criteria: Subjects with a history of systemic juvenile idiopathic arthritis (JIA), with or without systemic features. Subjects have active uveitis or a history of active uveitis within preceding 6 months to baseline. 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 (TNFalpha)antagonist drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Pharmacokinetics of Certolizumab Pegol (CZP) will be evaluated by collecting blood samples to measure the plasma concentration of CZP in µg per mL at Week 16, 48 and 248.;The immunogenicity of Certolizumab Pegol (CZP) will be evaluated by collecting blood samples to measure positive anti-CZP antibody results and determine the percentage of subjects with positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 16, 48 and 248 weeks.;The safety of Certolizumab Pegol (CZP) will be evaluated by collecting Adverse event information at every visit and determine the percentage of Subjects with at least one Adverse Event (AE) within the first 16, 56 and 248 weeks. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of Certolizumab Pegol (CZP) will be evaluated by recording Efficacy parameters at every visit. Efficacy parameters include questionnaires, physician´s, parent´s and/or child´s assessment of well-being and disease activity, physical and joint assessments, laboratory parameters. The results from these efficacy parameters will be used to determine the percentage of Subjects meeting American College of Rheumatology Pediatric 30 %, 50 %, 70 %, 90 % (PedACR30, PedACR50, PedACR70, PedACR90) Response Criteria at Week 16. The assessments of PedACR response rates are based on a 30 %, 50 %, 70 %, and 90 % or greater improvement in at least 3 of the following 6 core set measures with no more than 1 of the remaining worsened by >30 %, including: - Number of joints with active arthritis - Number of joints with limitation of range of motion - Physician’s Global Assessment of Disease Activity - Childhood Health Assessment Questionnaire (CHAQ) completed by parent or caregiver - Parent’s Global Assessment of Overall Well-Being - Acute phase reactant (CRP) | — |
Countries
Argentina, Brazil, Canada, Chile, Mexico, Russian Federation, United States
Contacts
Public ContactFábio Carbone de Moraes
Pharmaceutical Research Associates Ltda.
Outcome results
None listed