Trials / Completed
CompletedNCT01943526
Ireland Natalizumab (TYSABRI) Observational Program
Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 191 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
Detailed description
iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | natalizumab | Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician. |
Timeline
- Start date
- 2011-11-30
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
- First posted
- 2013-09-17
- Last updated
- 2018-05-04
Locations
5 sites across 1 country: Ireland
Source: ClinicalTrials.gov record NCT01943526. Inclusion in this directory is not an endorsement.