Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Biogen400 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Multiple Sclerosis

Interventions

natalizumabDRUG

Administered as specified in the treatment arm.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * All available retrospective and prospective data from pediatric MS patients who have received at least 1 dose of natalizumab before turning 18 years old and before 31 March 2015. * In addition, patients must be registered in TOUCH (US patients only), enrolled in a Biogen sponsored postmarketing observational study (e.g., TOP (NCT00493298) or TYGRIS (NCT00477113,NCT00483847)), or in a country-specific TYSABRI registry. * Adequate data received by Biogen by 30 September 2015 will be used for this meta-analysis including data collected after a patient may have turned 18 years old. Key Exclusion Criteria: * Data received by Biogen after 30 September 2015 will not be included in the statistical analyses NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Outcomes

Primary Outcomes

Incidence of all serious adverse events (SAEs)

Time frame: Up to 19 months

Data from ClinicalTrials.gov

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