Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137109
• Other study ID #: 101MS028
• Status: Completed
• Phase: N/A
• First received: May 1, 2014
• Last updated: October 16, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeSweden: Regional Ethical Review BoardDenmark: Ethics CommitteeGermany: Ethics CommissionFrance: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• natalizumab
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all serious adverse events (SAEs)		Up to 19 months	Yes