CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2008 |
| End Date: | August 2050 |
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
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).
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).
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.
with Biogen under a protocol written by Elan. Biogen is solely responsible for the study
since April 2013.
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:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
37
sites
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