Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

AbbVie

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01298648

P12-706

Details and patient eligibility

About

This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease.

Enrollment: 1,716 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Exclusion criteria

Contraindications according to the Package Insert

• Patients who have serious infections
• Patients who have tuberculosis
• Patients with a history of hypersensitivity to any ingredient of Humira
• Patients who have demyelinating disease or with a history of demyelinating disease
• Patients who have congestive cardiac failure

Trial design

1,716 participants in 1 patient group

Humira

Description:

Participants who were prescribed Humira per approved prescribing information of Humira in Japan.