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