Status:
COMPLETED
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
Lead Sponsor:
UCB Japan Co. Ltd.
Conditions:
Crohn's Disease
Eligibility:
All Genders
16-64 years
Phase:
PHASE2
Brief Summary
This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study...
Detailed Description
In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were elig...
Eligibility Criteria
Inclusion
- Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy
Exclusion
- Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00329550
Start Date
May 1 2006
End Date
April 1 2008
Last Update
March 18 2015
Active Locations (23)
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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