Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)

AbbVie

Status: Completed

Conditions: Behcet's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01960790

P14-152

Details and patient eligibility

About

This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.

1. Incidence and conditions of occurrence of adverse reactions in clinical practice
2. Factors likely to affect the safety and effectiveness

Enrollment: 473 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)

Exclusion criteria

Contraindications according to the Package Insert include patients who had any of the following:

• serious infections
• tuberculosis
• a history of hypersensitivity to any ingredient of Humira®
• demyelinating disease or a history of demyelinating disease
• congestive cardiac failure

Trial design

473 participants in 1 patient group

Participants who received Humira®

Description:

Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration