Special Investigation in Patients With Ulcerative Colitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-09

Study Completion Date

2018-02-15

Brief Summary

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This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.

1. Unknown adverse reactions (in particular, clinically significant)
2. Incidence and conditions of occurrence of adverse reactions in clinical practice
3. Factors likely to affect the safety and effectiveness

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Humira

Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

Exclusion Criteria

Contraindications according to the Package Insert include patients who have 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

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No