Trials / Terminated
TerminatedNCT00707512
CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 87 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | natalizumab | Administered as specified in the TOUCH Prescribing Program |
Timeline
- Start date
- 2008-06-30
- Primary completion
- 2015-05-28
- Completion
- 2015-05-28
- First posted
- 2008-07-01
- Last updated
- 2024-06-03
Locations
36 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00707512. Inclusion in this directory is not an endorsement.