Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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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

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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natalizumab

Natalizumab will not be provided as a part of this study. Participants will receive natalizumab per the local label specifications.

natalizumab

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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natalizumab

Administered as specified in the treatment arm.

Intervention Type DRUG

Other Intervention Names

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BG00002 Tysabri

Eligibility Criteria

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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.