Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Biogen

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Drug: natalizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT02137109

101MS028

Details and patient eligibility

About

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

Full 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.

Enrollment

400 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: