CD 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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring|
- Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab [ Time Frame: Every 6 months for up to 5 years following the first Tysabri infusion ] [ Designated as safety issue: Yes ]
- Measurement of disease severity over time as assessed by change in HBI [ Time Frame: Every 6 months for up to 5 years following the first Tysabri infusion ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||August 2050|
|Estimated Primary Completion Date:||August 2050 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707512
Show 36 Study Locations
|Study Director:||Medical Director||Biogen|