Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

October 16, 2015 updated by: Biogen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric MS patients who have received at least 1 dose of natalizumab prior to the age of 18 years where the first dose was administered prior to 31 March 2015.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
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:
  • Tysabri
  • BG00002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of all serious adverse events (SAEs)
Time Frame: Up to 19 months
Up to 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101MS028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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