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

November 26, 2020 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia
        • 301
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • 203
    • Ontario
      • Hamilton, Ontario, Canada
        • 204
  • United States
    • California
      • Orange, California, United States
        • 114
    • Colorado
      • Aurora, Colorado, United States
        • 111
    • Georgia
      • Atlanta, Georgia, United States
        • 103
      • Atlanta, Georgia, United States
        • 116
    • Louisiana
      • Shreveport, Louisiana, United States
        • 112
    • Maryland
      • Baltimore, Maryland, United States
        • 104
    • New Jersey
      • Morristown, New Jersey, United States
        • 126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Cimzia®
  • Crohn's Disease
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:
  • Cimzia®
  • Crohn's Disease
Experimental: Certolizumab pegol: low-dose group (weight adjusted)
200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 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:
  • Cimzia®
  • Crohn's Disease
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:
  • Cimzia®
  • Crohn's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
Time Frame: During study treatment (up to 303 weeks)
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
During study treatment (up to 303 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
Time Frame: During study treatment (up to 303 weeks)
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
During study treatment (up to 303 weeks)
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
Time Frame: At the time of completion or termination visit (up to 298 weeks)
Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
At the time of completion or termination visit (up to 298 weeks)
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Time Frame: At the time of completion or termination visit (up to 298 weeks)
Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
At the time of completion or termination visit (up to 298 weeks)
Percentage of Subjects in Clinical Remission
Time Frame: At the time of completion or termination visit (up to 298 weeks)
Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
At the time of completion or termination visit (up to 298 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877-822-9493 UCB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 27, 2017

Study Completion (Actual)

November 27, 2017

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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