Overview

This trial is active, not recruiting.

Condition polyarticular-course juvenile idiopathic arthritis (jia)
Treatment certolizumab pegol (czp)
Phase phase 3
Sponsor UCB BIOSCIENCES GmbH
Collaborator PRA Health Sciences
Start date March 2012
End date March 2018
Trial size 163 participants
Trial identifier NCT01550003, RA0043

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Active treatment with Certolizumab Pegol; dose adjustment is based on weight.
certolizumab pegol (czp) Cimzia
CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution. Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range: 10 to < 20 kg: Loading dose = 50 mg Q2W (1 x 0.25 mL sc); treatment dose = 50 mg Q4W (1 x 0.25 mL sc); 20 to < 40 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc,); treatment dose = 50 mg Q2W (1 x 0.25 mL sc); ≥ 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);

Primary Outcomes

Measure
Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 16
time frame: Week 16
Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 48
time frame: Week 48
Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 248
time frame: Week 248
Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 16 weeks
time frame: Within the first 16 weeks
Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 48 weeks
time frame: Within the first 48 weeks
Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within 248 weeks
time frame: Within 248 weeks
Percentage of Subjects with at least one Adverse Event (AE) within the first 16 weeks
time frame: Within the first 16 weeks
Percentage of Subjects with at least one Adverse Event (AE) within the first 56 weeks
time frame: Within the first 56 weeks
Percentage of Subjects with at least one Adverse Event (AE) within 248 weeks
time frame: Within 248 weeks

Secondary Outcomes

Measure
Percentage of Subjects meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
time frame: Baseline to Week 16
Percentage of Subjects meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16
time frame: Baseline to Week 16
Percentage of Subjects meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16
time frame: Baseline to Week 16
Percentage of Subjects meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16
time frame: Baseline to Week 16

Eligibility Criteria

Male or female participants from 2 years up to 17 years old.

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

Additional Information

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)
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.