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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01243671
• Date of registration: 17/11/2010
• Prospective Registration: No
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
• Scientific title: A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
• Date of first enrolment: October 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01243671
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Morio Ozawa, MS
• Affiliation: AbbVie GK

Key inclusion & 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



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intestinal Behçet's Disease

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Number of Participants With Marked Improvement at Week 24 [Time Frame: 24 weeks]

Secondary Outcome(s)

Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52 [Time Frame: Baseline, 24 weeks, 52 weeks]

Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52 [Time Frame: Baseline, 24 weeks, 52 weeks]

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 [Time Frame: 24 weeks, 52 weeks]

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 [Time Frame: 24 weeks, 52 weeks]

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52 [Time Frame: Baseline, 24 weeks, 52 weeks]

Number of Participants With Endoscopic Improvement Grades 0, =1 and =2 at Week 24 and Week 52 [Time Frame: 24 weeks, 52 weeks]

Number of Participants With Complete Remission at Week 24 and Week 52 [Time Frame: 24 weeks, 52 weeks]

Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52 [Time Frame: 24 weeks, 52 weeks]

Number of Participants With Marked Improvement at Week 52 [Time Frame: 52 weeks]

Secondary ID(s)

M11-509

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eisai Co., Ltd.

Results

• Results available: Yes
• Date Posted: 15/05/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01243671