Status:
COMPLETED
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Intestinal Behçet's Disease
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.
Eligibility Criteria
Inclusion
- Intestinal Behçet's disease
- Patients with typical ulcer at ileocecal region
- Patients who have failed conventional treatment
Exclusion
- Crohn's disease
- History of ileocecal resection
- History of tuberculosis (TB)
- Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01243671
Start Date
October 1 2010
End Date
June 1 2013
Last Update
July 25 2014
Active Locations (12)
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1
Site Reference ID/Investigator# 46738
Chikushino-shi, Japan
2
Site Reference ID/Investigator# 46723
Kurume, Japan
3
Site Reference ID/Investigator# 46728
Nagoya, Japan
4
Site Reference ID/Investigator# 46725
Nishinomiya-shi, Japan