Trials / Completed
CompletedNCT02137109
Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.
Detailed description
All available retrospective and prospective data from pediatric MS participants who have received at least 1 dose of natalizumab before turning 18 years old and before 31Mar2015 will be used in this study. Prospective data are defined as data to be collected in the future, i.e., from new participants not included in the first data transfer or additional data from existing participants that were not included in the first data transfer. Existing biospecimen samples will be evaluated but not collected as part of this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | natalizumab | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2014-05-13
- Last updated
- 2015-10-20
Source: ClinicalTrials.gov record NCT02137109. Inclusion in this directory is not an endorsement.