Status:
TERMINATED
CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Lead Sponsor:
Biogen
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief 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 wi...
Detailed 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 30 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 28 2015
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00707512
Start Date
June 30 2008
End Date
May 28 2015
Last Update
June 3 2024
Active Locations (36)
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1
Research site
Scottsdale, Arizona, United States, 85260
2
Research site
Oceanside, California, United States, 92056
3
Research site
San Francisco, California, United States, 94115
4
Research site
Hamden, Connecticut, United States, 06518