Status:
COMPLETED
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
Lead Sponsor:
UCB Pharma SA
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation...
Eligibility Criteria
Inclusion
- Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 \[NCT00152490\] or the Week 6 randomization in CDP870-032 \[NCT00152425\] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
- At least 70 points higher then Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870 032 \[NCT00152425\] responders) OR
- Higher than Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870-032 \[NCT00152425\] responders) with an absolute score of at least 350 points
- 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 upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00160706
Start Date
February 1 2004
End Date
May 1 2012
Last Update
August 7 2018
Active Locations (141)
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45102
Birmingham, Alabama, United States
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45028
Huntsville, Alabama, United States
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45044
Little Rock, Arkansas, United States
4
45095
Orange, California, United States