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

Crohn's Disease Clinical Trial

— COSPAR II  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356408
• Other study ID #: C87065
• Secondary ID: 2006-003871-11
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: February 2010

Study information

• Verified date: April 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Certolizumab pegol
Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)a, 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of at Least One Treatment-emergent Adverse Event 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.	During this study (maximum 122 weeks)
Secondary	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.	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.	Week 34 in this study

External Links

•   FDA Safety Alerts and Recalls
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