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Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: natalizumab (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

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

Clinical Details

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

Study design: Observational Model: Case-Only

Primary outcome: Incidence of all serious adverse events (SAEs)

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 31 March 2015 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.

Eligibility

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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 Idec sponsored postmarketing observational study (e. g., TOP (NCT00493298) or TYGRIS (NCT00477113,NCT00483847)), or in a country-specific TYSABRI registry.

- Adequate data received by Biogen Idec 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 Idec after 30 September 2015 will not be included in the

statistical analyses NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Locations and Contacts

Additional Information

Starting date: March 2014
Last updated: July 31, 2015

Page last updated: August 23, 2015

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