CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

• Status: Terminated
• Trial end date: 2050-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Natalizumab

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.