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Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT02137109
Collaborator
(none)
400
Enrollment
19
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
400 participants
Observational Model:
Case-Only
Official Title:
Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
natalizumab

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

Drug: natalizumab
Administered as specified in the treatment arm.
Other Names:
  • BG00002
  • Tysabri

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of all serious adverse events (SAEs) [Up to 19 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT02137109
    Other Study ID Numbers:
    • 101MS028
    First Posted:
    May 13, 2014
    Last Update Posted:
    Oct 20, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Biogen
    Pediatric
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Natalizumab

    Study Results

    No Results Posted as of Oct 20, 2015