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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 October 2015 |
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Main ID: |
NCT02137109 |
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Date of registration:
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01/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
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Scientific title:
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Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02137109 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only
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Phase:
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N/A
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: natalizumab
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Primary Outcome(s)
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Incidence of all serious adverse events (SAEs)
[Time Frame: Up to 19 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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