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Trial record 1 of 1 for:    NCT01190410
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Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01190410
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : March 26, 2019
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Crohn's Disease Drug: certolizumab pegol Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190410


Locations
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United States, California
114
Orange, California, United States
United States, Colorado
111
Aurora, Colorado, United States
United States, Georgia
103
Atlanta, Georgia, United States
116
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
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Study Director: UCB Clinical Trial Call Center +1 877-822-9493 UCB
  Study Documents (Full-Text)

Documents provided by UCB Pharma:
Study Protocol  [PDF] May 8, 2012
Statistical Analysis Plan  [PDF] January 1, 2018

More Information
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Additional Information:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01190410    
Other Study ID Numbers: CR0012
First Posted: August 27, 2010    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: December 17, 2020
Last Verified: November 2020
Keywords provided by UCB Pharma:
Certolizumab Pegol
Cimzia®
Crohn's Disease
Children and Adolescents with Crohn's Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
 Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents