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Trial record 1 of 1 for:    NCT02137109
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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
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: natalizumab

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 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.

Study Design

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Only
Official Title: Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis
Study Start Date : March 2014
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
natalizumab
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab per the local label specifications.
Drug: natalizumab
Administered as specified in the treatment arm.
Other Names:
  • BG00002
  • Tysabri


Outcome Measures

Primary Outcome Measures :
  1. Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 19 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Study Population
Pediatric MS patients who have received at least 1 dose of natalizumab prior to the age of 18 years where the first dose was administered prior to 31 March 2015.
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 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

Contacts and Locations

Information from the National Library of Medicine

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


Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02137109     History of Changes
Other Study ID Numbers: 101MS028
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Biogen:
Pediatric

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs