Special Investigation in Patients With Ulcerative Colitis

HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis

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

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