CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring (INFORM)
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ClinicalTrials.gov Identifier: NCT00707512
Recruitment Status :
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).
Condition or disease
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.
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 ]
Secondary Outcome Measures :
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.