A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Study ID
- NCT01243671
- Phase
- PHASE3
- Status
- Completed
Conditions
- Intestinal Behçet's Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Adalimumab — BIOLOGICAL
Study Details
To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.
Key Dates
- Start date
- Oct 31, 2010
- Status verified
- Jun 2014
- Primary completion
- Mar 31, 2012
- Completion
- Jun 30, 2013
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: AdalimumabAdalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
Primary Outcome Measure
Number of Participants With Marked Improvement at Week 24 [ Time Frame: 24 weeks ]