Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01190410
First received: August 25, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.


Condition Intervention Phase
Crohn's Disease
Drug: certolizumab pegol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during study treatment (up to 416 weeks) [ Time Frame: During study treatment (up to 416 weeks) ] [ Designated as safety issue: No ]
    Treatment emergent adverse events will be summarized descriptively by primary system organ class (SOC), high level term, and preferred term (PT).


Secondary Outcome Measures:
  • Number of subjects discontinuing treatment due to a Treatment-emergent Adverse Event (TEAE) [ Time Frame: During study treatment (up to 416 weeks) ] [ Designated as safety issue: No ]
  • Number of subjects who develop anti-nuclear antibodies during the study [ Time Frame: During study treatment (up to 416 weeks) ] [ Designated as safety issue: No ]
  • Number of subjects who develop double-stranded deoxyribonucleic acid (dsDNA) antibodies during the study [ Time Frame: During study treatment (up to 416 weeks) ] [ Designated as safety issue: No ]
  • Percentage of subjects in clinical remission [ Time Frame: During study treatment (up to 416 weeks) ] [ Designated as safety issue: No ]
    Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)


Enrollment: 16
Study Start Date: August 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab pegol: high-dose group
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
Drug: certolizumab pegol
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
Other Names:
  • Certolizumab Pegol
  • Cimzia®
  • Crohn's Disease
Experimental: Certolizumab pegol: low-dose group (weight adjusted)
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
Drug: certolizumab pegol
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Other Names:
  • Certolizumab Pegol
  • Cimzia®
  • Crohn's Disease

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments when their participation in C87035 was terminated when the study was stopped by UBC
  • Subject completed all assessments required for Week 62/Visit 23 at the time of termination
  • Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD) throughout study

Exclusion Criteria:

  • Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did not complete all of the Week 62 assessments when their participation from C87035 was terminated when the study was stopped by UCB but did not complete all assessments required for Week 62/Visit 23 at the time of termination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190410

Locations
United States, California
114
Orange, California, United States
United States, Colorado
111
Aurora, Colorado, United States
United States, Georgia
116
Atlanta, Georgia, United States
103
Atlanta, Georgia, United States
United States, Louisiana
112
Shreveport, Louisiana, United States
United States, Maryland
104
Baltimore, Maryland, United States
United States, New Jersey
126
Morristown, New Jersey, United States
Australia, Victoria
301
Parkville, Victoria, Australia
Canada, Alberta
203
Edmonton, Alberta, Canada
Canada, Ontario
204
Hamilton, Ontario, Canada
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877-822-9493 UCB
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01190410     History of Changes
Other Study ID Numbers: CR0012
Study First Received: August 25, 2010
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by UCB Pharma:
Certolizumab Pegol
Cimzia®
Crohn's Disease
Children and Adolescents with Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014