A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

Study Identifier
M11-509
CT.gov Identifier
NCT01243671
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Immune & Inflammatory - Other
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Intestinal Behçet's disease * Patients with typical ulcer at ileocecal region * Patients who have failed conventional treatment
    Exclusion Criteria:
    * 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 46738
    Chikushino-shi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46723
    Kurume, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46728
    Nagoya, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46725
    Nishinomiya-shi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46730
    Osaka, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46722
    Sagamihara-shi, Japan
    Status
    Not applicable
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