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Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137109
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date May 1, 2014
First Posted Date May 13, 2014
Last Update Posted Date October 20, 2015
Study Start Date March 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2014)
Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 19 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
Official Title Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis
Brief Summary The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.
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 Type Observational
Study Design Observational Model: Case-Only
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Multiple Sclerosis
Intervention Drug: natalizumab
Administered as specified in the treatment arm.
Other Names:
  • BG00002
  • Tysabri
Study Groups/Cohorts natalizumab
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab per the local label specifications.
Intervention: Drug: natalizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 9, 2014)
400
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02137109
Other Study ID Numbers 101MS028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date October 2015