drugset / Trial / NCT01243671
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-10
- Primary completion
- 2012-03
- Completion
- 2013-06
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |