Status:
COMPLETED
A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
Lead Sponsor:
UCB Pharma SA
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT0015242...
Eligibility Criteria
Inclusion
- Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
- Subjects must be able to understand the information provided to them and give written informed consent
Exclusion
- Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00160524
Start Date
July 1 2004
End Date
August 1 2012
Last Update
August 1 2018
Active Locations (206)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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Orange, California, United States