Clinical trial NCT01243671: A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Official title: A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intestinal Behçet's Disease
Keywords: Behçet's, intestinal
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2010-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants With Marked Improvement at Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Participants With Marked Improvement at Week 52
timeFrame: 52 weeks
measure: Number of Participants With Complete Remission at Week 24 and Week 52
timeFrame: 24 weeks, 52 weeks
measure: 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
timeFrame: 24 weeks, 52 weeks
measure: Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
timeFrame: 24 weeks, 52 weeks
measure: 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
timeFrame: 24 weeks, 52 weeks
measure: Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
timeFrame: 24 weeks, 52 weeks
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52
timeFrame: Baseline, 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Chikushino
country: Japan
facility: Site Reference ID/Investigator# 46738
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 46723
city: Nagoya-shi
country: Japan
facility: Site Reference ID/Investigator# 46728
city: Nishinomiya-shi
country: Japan
facility: Site Reference ID/Investigator# 46725
city: Osaka-shi
country: Japan
facility: Site Reference ID/Investigator# 46730
city: Sagamihara-shi
country: Japan
facility: Site Reference ID/Investigator# 46722
city: Sakura
country: Japan
facility: Site Reference ID/Investigator# 46726
city: Sapporo-shi
country: Japan
facility: Site Reference ID/Investigator# 59578
city: Takatsuki-shi
country: Japan
facility: Site Reference ID/Investigator# 46724
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 46729
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 46737
city: Yokohama-shi
country: Japan
facility: Site Reference ID/Investigator# 46733
Study officials:
affiliation: AbbVie
name: Morio Ozawa, MS
role: STUDY_DIRECTOR
References:
citation: Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, Huang B, Robinson AM, Thakkar RB, Hibi T. Long-term safety and efficacy of adalimumab for intestinal Behcet's disease in the open label study following a phase 3 clinical trial. Intest Res. 2017 Jul;15(3):395-401. doi: 10.5217/ir.2017.15.3.395. Epub 2017 Jun 12.
citation: Tanida S, Inoue N, Kobayashi K, Naganuma M, Hirai F, Iizuka B, Watanabe K, Mitsuyama K, Inoue T, Ishigatsubo Y, Suzuki Y, Nagahori M, Motoya S, Nakamura S, Arora V, Robinson AM, Thakkar RB, Hibi T. Adalimumab for the treatment of Japanese patients with intestinal Behcet's disease. Clin Gastroenterol Hepatol. 2015 May;13(5):940-8.e3. doi: 10.1016/j.cgh.2014.08.042. Epub 2014 Sep 19.