A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
NCT ID: NCT01243671
Last Updated: 2014-07-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2010-10-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT00853099
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
NCT00445939
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
NCT00445432
A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
NCT01863771
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
NCT02632175
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adalimumab
Adalimumab 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.
Adalimumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adalimumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with typical ulcer at ileocecal region
* Patients who have failed conventional treatment
Exclusion Criteria
* History of ileocecal resection
* History of tuberculosis (TB)
* Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Co., Ltd.
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Morio Ozawa, MS
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site Reference ID/Investigator# 46738
Chikushino-shi, , Japan
Site Reference ID/Investigator# 46723
Kurume, , Japan
Site Reference ID/Investigator# 46728
Nagoya, , Japan
Site Reference ID/Investigator# 46725
Nishinomiya-shi, , Japan
Site Reference ID/Investigator# 46730
Osaka, , Japan
Site Reference ID/Investigator# 46722
Sagamihara-shi, , Japan
Site Reference ID/Investigator# 46726
Sakura, , Japan
Site Reference ID/Investigator# 59578
Sapporo, , Japan
Site Reference ID/Investigator# 46724
Takatsuki-shi, , Japan
Site Reference ID/Investigator# 46729
Tokyo, , Japan
Site Reference ID/Investigator# 46737
Tokyo, , Japan
Site Reference ID/Investigator# 46733
Yokohama, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M11-509
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.