Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries

NCT03399981 | Completed FDA Drug

• 2 other identifiers: 101MS411EUPAS19800
• Study Type: observational
• Target: 80,327
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)

Conditions

Progressive Multifocal Leukoencephalopathy

Outcome Measures

Primary Outcomes (2)

• Prospective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML)

  Confirmed cases of PML must have one of the following: • Brain biopsy or brain from post mortem examination showing evidence of viral cytopathic changes on hematoxylin and eosin (H \& E) staining associated with either positive immunohistochemistry for SV40 or in-situ hybridization for John Cunningham Virus (JCV) deoxyribonucleic acid (DNA) OR All of the following criteria: • Cerebrospinal fluid (CSF) with evidence of JCV DNA, preferably by ultra-sensitive quantitative polymerase chain reaction (PCR) testing (limit of quantification of ≤ 50 copies/ml), or JCV DNA on brain biopsy by PCR AND detailed description of brain magnetic resonance imaging (MRI) findings that are consistent with PML AND PREFERABLY new or progressive clinical symptoms suggestive of PML

  Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 years)

• Prospective and Retrospective Analyses: Number of Participants with Serious Adverse Events of Other Serious Opportunistic Infections (OIs)

  An SAE is any untoward medical occurrence at any dose that results in death, immediate risk of death, hospitalization, disability, or congenital anomaly/birth defect. Opportunistic infections (OIs) are infections that occur more frequently and are more severe in individuals with weakened immune systems.

  Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 years)

Study Arms (2)

Tysabri (TOUCH Cohort)

Participants from the Tysabri TOUCH prescribing programme who have switched to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate).

Biological: Tysabri

Tysabri (EU MS Cohort)

Participants from the EU MS registry who have switched to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate).

Biological: Tysabri

Interventions

Tysabri BIOLOGICAL

Administered as specified in the treatment arm.

Also known as: Natalizumab BG00002

Tysabri (EU MS Cohort); Tysabri (TOUCH Cohort)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.

You may qualify if:

• All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Leukoencephalopathy, Progressive Multifocal

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Demyelinating Diseases; Neuroinflammatory 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: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: June 1, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

US (1)