CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
- Conditions
- Crohn's Disease
- Registration Number
- NCT00707512
- Lead Sponsor
- Biogen
- 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 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).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 87
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab Every 6 months for up to 5 years following the first Tysabri infusion
- Secondary Outcome Measures
Name Time Method Measurement of disease severity over time as assessed by change in HBI Every 6 months for up to 5 years following the first Tysabri infusion
Trial Locations
- Locations (1)
Research site
🇵🇷San Juan, Puerto Rico