Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
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|ClinicalTrials.gov Identifier: NCT02137109|
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : October 20, 2015
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|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: natalizumab|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
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.
- Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 19 months ]
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|Ages Eligible for Study:||up to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137109
|Study Director:||Medical Director||Biogen|
|Other Study ID Numbers:||
|First Posted:||May 13, 2014 Key Record Dates|
|Last Update Posted:||October 20, 2015|
|Last Verified:||October 2015|
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs