Status:
COMPLETED
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
16-64 years
Phase:
PHASE2
Brief Summary
This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's di...
Detailed Description
This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the double-blind main ...
Eligibility Criteria
Inclusion
- Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) \[reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)\]
Exclusion
- Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00329420
Start Date
May 1 2006
End Date
May 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