Clinical Trial: Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis

Brief Summary: The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.

Detailed Summary: 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.
Sponsor: Biogen

Current Primary Outcome: Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 19 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Biogen

Dates:
Date Received: May 1, 2014
Date Started: March 2014
Date Completion:
Last Updated: October 16, 2015
Last Verified: October 2015