Special Investigation in Patients With Ulcerative Colitis

AbbVie

Status: Completed

Conditions: Ulcerative Colitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01947816

P14-190

Details and patient eligibility

About

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

Enrollment: 1,621 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,621 participants in 1 patient group

Humira

Description:

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.