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Trial record 1 of 1 for:    NCT00356408
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Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)

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: NCT00356408
Recruitment Status : Completed
First Posted : July 26, 2006
Results First Posted : May 25, 2011
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Certolizumab pegol Phase 3

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 : 106 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).
Study Start Date : January 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
 Biological: Certolizumab pegol

Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).

Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.

Other Names:
  • CDP870
  • CZP
  • Cimzia


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) [ Time Frame: During this study (maximum 122 weeks) ]
    Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.


Secondary Outcome Measures :
  1. Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. [ Time Frame: Week 34 in this study ]
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

Exclusion Criteria:

  • Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
  • Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
  • Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
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): NCT00356408


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Additional Information:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00356408    
Other Study ID Numbers: C87065
2006-003871-11 ( EudraCT Number )
First Posted: July 26, 2006    Key Record Dates
Results First Posted: May 25, 2011
Last Update Posted: August 9, 2018
Last Verified: April 2011
Keywords provided by UCB Pharma:
CDP870
certolizumab pegol
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