Status:
COMPLETED
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Lead Sponsor:
Abbott
Collaborating Sponsors:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Conditions:
Crohn's Disease
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
Eligibility Criteria
Inclusion
- Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450
- If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
Exclusion
- Ulcerative colitis or indeterminate colitis
- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
- Body weight is below 30 kg
- Surgical bowel resections within the past 6 months
- Females who are pregnant or breast-feeding or considering becoming pregnant during the study
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00445939
Start Date
February 1 2007
Last Update
June 27 2011
Active Locations (18)
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1
Aichi, Japan
2
Chiba, Japan
3
Ehime, Japan
4
Fukuoka, Japan