Clinical Trial: Pediatric Arthritis Study of Certolizumab Pegol
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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 I
Brief 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).
Detailed Summary:
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.
Sponsor: UCB BIOSCIENCES GmbH
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
- 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 186 [ Time Frame: Week 186 ]
- Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
- Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
- Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result from Baseline to Week 186 [ Time Frame: Baseline to Week 186 ]
- Percentage of Subjects with at least one Adverse Event (AE) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
- Percentage of Subjects with at least one Adverse Event (AE) from Baseline to Week 56 [ Time Frame: Baseline to Week 56 ]
- Percentage of Subjects with at least one Adverse Event (AE) from Baseline to Week 186 [ Time Frame: Baseline to Week 186 ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: UCB Pharma
Dates:
Date Received: March 7, 2012
Date Started: March 2012
Date Completion: May 2018
Last Updated: May 3, 2017
Last Verified: May 2017