Phase 3
N=20
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Intestinal Behçet's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01243671 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
May 2013
Primary outcome: Primary: Number of Participants With Marked Improvement at Week 24 — 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Biological)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Marked Improvement at Week 24 |
9 | — |
| SECONDARY Number of Participants With Marked Improvement at Week 52 |
12 | — |
| SECONDARY Number of Participants With Complete Remission at Week 24 and Week 52 |
4; 4 | — |
| SECONDARY Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52 |
9; 13; 16; 9; 16; 18 | — |
| SECONDARY Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52 |
9; 12; 15; 11; 13; 15 | — |
| SECONDARY Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52 |
11; 13; 16; 14; 11; 18 | — |
| SECONDARY Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52 |
10; 6; 0; 2; 10; 7 | — |
| SECONDARY Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52 |
37.1; 41.2 | — |
| SECONDARY Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52 |
7.5; 8.9; 9.0; 9.0 | — |
| SECONDARY Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52 |
-0.3; -0.2 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01243671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.