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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00356408
First received: July 25, 2006
Last updated: August 26, 2014
Last verified: April 2011

July 25, 2006
August 26, 2014
January 2007
February 2010   (final data collection date for primary outcome measure)
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) [ Time Frame: During this study (maximum 122 weeks) ] [ Designated as safety issue: No ]
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
The primary objective is to continue to assess safety of certolizumab pegol as per adverse events reporting.
Complete list of historical versions of study NCT00356408 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
• To describe the evolution of long term efficacy (through maintenance of clinical remission) in Crohn’s disease patients who have completed COSPAR I study.
Not Provided
Not Provided
 
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
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).

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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
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
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
Intervention: Biological: Certolizumab pegol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Canada
 
NCT00356408
C87065, 2006-003871-11
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP