CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Biogen

Status: Terminated

Conditions: Crohn's Disease

Treatments: Drug: natalizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT00707512

101CD401

ELN100226-CD451 (Other Identifier)

Details and patient eligibility

About

The primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (SAE) in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index (HBI).

Full description

This study was originally conducted by Elan Pharmaceuticals, Inc. (Elan) in collaboration with Biogen under a protocol written by Elan. Biogen is solely responsible for the study since April 2013.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects with Crohn's Disease (CD) who are eligible for therapy according to US Tysabri label and who are enrolled in the Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program.

Key Exclusion criteria:

• None

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.