Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
What it found
We found no results in the registry or in papers.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Incidence of all serious adverse events (SAEs)
Up to 19 months
Safety
Who could take part
MS (type not specified) · Up to 18
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.
Papers
Loading reviews and guidelines…
Linked trials
Refers to
TYGRIS - ROWCompleted
Refers to
TYGRISCompleted
Refers to
TOPCompleted
Links found where a registry record names another trial's registry number.
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History
Started
Mar 2014
Main results due
Oct 2015
Finished
Oct 2015
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