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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

473 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-25

Study Completion Date

2017-05-15

Brief Summary

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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

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Detailed Description

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Conditions

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Behcet's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants who received Humira®

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

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No