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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Intestinal Behçet's Disease

Treatments: Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243671

M11-509

Details and patient eligibility

About

To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.

Enrollment: 20 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Adalimumab

Experimental group

Description:

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.

Treatment:

Biological: Adalimumab