Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

NCT02137109 | Completed

• 1 other identifier: 101MS028
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• Incidence of all serious adverse events (SAEs)

  Up to 19 months

Study Arms (1)

natalizumab

Natalizumab will not be provided as a part of this study. Participants will receive natalizumab per the local label specifications.

Drug: natalizumab

Interventions

natalizumab DRUG

Administered as specified in the treatment arm.

Also known as: BG00002, Tysabri

natalizumab

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Data received by Biogen after 30 September 2015 will not be included in the statistical analyses

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 13, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10