Trials / Completed
CompletedNCT00493298
Tysabri Observational Program
TOP: TYSABRI Observational Program
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,620 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
Detailed description
TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tysabri | According to the local prescribing information |
Timeline
- Start date
- 2007-06-29
- Primary completion
- 2023-11-01
- Completion
- 2023-11-01
- First posted
- 2007-06-28
- Last updated
- 2024-04-08
Locations
419 sites across 18 countries: Argentina, Australia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Norway, Portugal, Slovakia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00493298. Inclusion in this directory is not an endorsement.