Status:
COMPLETED
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
Eligibility Criteria
Inclusion
- Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders \[Shimoyama group, January 25, 2002\]) at least 24 weeks before the starting date of the observation period
- Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
- C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period
Exclusion
- Stoma patient
- Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
- Patients who participated in a clinical study with CDP870
- Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
- Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators
Key Trial Info
Start Date :
March 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2007
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00291668
Start Date
March 2 2006
End Date
November 8 2007
Last Update
August 3 2020
Active Locations (22)
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1
Aichi-Gun, Aichi-ken, Japan
2
Nagoya, Aichi-ken, Japan
3
Toyoake, Aichi-ken, Japan
4
Toyohashi, Aichi-ken, Japan