- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02137109
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
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.
|
Administered as specified in the treatment arm.
Other Names:
|
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
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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