Status:
TERMINATED
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease...
Eligibility Criteria
Inclusion
- Men and women
- Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)
Exclusion
- Active or draining fistula present at screening
- Lactating and/or pregnant female subjects
- A history of any health condition that could potentially interfere with the disease and/or the treatment
- A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
- Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
- History of drug or alcohol abuse in the prior year
- Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00349752
Start Date
November 1 2006
End Date
July 1 2009
Last Update
August 9 2018
Active Locations (68)
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1
Birmingham, Alabama, United States
2
Montgomery, Alabama, United States
3
Tucson, Arizona, United States
4
La Jolla, California, United States