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

Intervention model single group assignment
Primary purpose treatment
Masking no masking
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

All 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 March 2017.
Information provided to ClinicalTrials.gov by UCB Pharma.