Status:
COMPLETED
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
Lead Sponsor:
Abbott
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Crohn's Disease
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
PHASE3
Brief Summary
To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.
Detailed Description
This was a Phase 2/3, multicenter, randomized, double-blind (DB), placebo-controlled, two-arm, efficacy, safety, and pharmacokinetic study designed to demonstrate the effectiveness of adalimumab in Ja...
Eligibility Criteria
Inclusion
- Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study
Exclusion
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00445432
Start Date
March 1 2007
End Date
November 1 2010
Last Update
February 2 2012
Active Locations (29)
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1
Site Ref # / Investigator 46965
Aichi, Japan
2
Site Ref # / Investigator 46977
Aichi, Japan
3
Site Ref # / Investigator 46978
Aichi, Japan
4
Site Ref # / Investigator 46979
Aichi, Japan