- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03399981
Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an observational cohort study utilising all available data from the Tysabri TOUCH (TYSABRI Outreach: Unified Commitment to Health) prescribing programme (US) supplemented with data from European Union (EU) multiple sclerosis (MS) registries to estimate the risk of PML and other serious opportunistic infections (OIs) among patients on Tysabri who have switched from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate).
This study will provide cumulative data from its two components: a retrospective component (data captured prior to 01 January 2016) and a prospective component (data captured, and patients followed up, from 01 January 2016 through 31 December 2023; total prospective study duration of 8 years). All patients who switched to Tysabri from another DMT through 31 December 2020 will be included. The study will continue to follow-up patients until 31 December 2023 to allow for a minimal follow-up of 3 years.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Cambridge, Massachusetts, United States, 02142
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- Not applicable
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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).
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Administered as specified in the treatment arm.
Other Names:
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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).
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Administered as specified in the treatment arm.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prospective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML)
Time Frame: 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)
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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)
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Prospective and Retrospective Analyses: Number of Participants with Serious Adverse Events of Other Serious Opportunistic Infections (OIs)
Time Frame: 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)
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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)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Biogen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Virus Diseases
- Infections
- Demyelinating Diseases
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- DNA Virus Infections
- Slow Virus Diseases
- Encephalitis
- Polyomavirus Infections
- Neuroinflammatory Diseases
- Leukoencephalopathy, Progressive Multifocal
- Leukoencephalopathies
- Physiological Effects of Drugs
- Immunologic Factors
- Natalizumab
Other Study ID Numbers
- 101MS411
- EUPAS19800 (Registry Identifier: EU PAS Register)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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