Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
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ClinicalTrials.gov Identifier: NCT03399981 |
Recruitment Status :
Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : June 14, 2019
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Condition or disease | Intervention/treatment |
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Progressive Multifocal Leukoencephalopathy | Biological: Tysabri |
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 separately: a retrospective component (data captured prior to 1 January 2016) and a prospective component (data captured, and patients followed up, from 1 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 : | Observational |
Actual Enrollment : | 72600 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Official Title: | 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 |
Actual Study Start Date : | January 24, 2018 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Group/Cohort | Intervention/treatment |
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Tysabri (TOUCH Cohort)
Patients 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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Biological: Tysabri
Administered as specified in the treatment arm.
Other Name: Natalizumab BG00002 |
Tysabri (EU MS Cohort)
Patients 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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Biological: Tysabri
Administered as specified in the treatment arm.
Other Name: Natalizumab BG00002 |
- 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) ]
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
- 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) ]
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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Key Inclusion Criteria:
- All TOUCH and available EU MS registry patients 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:
-
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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): NCT03399981
United States, Massachusetts | |
Research Site | |
Cambridge, Massachusetts, United States, 02142 |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT03399981 |
Other Study ID Numbers: |
101MS411 |
First Posted: | January 17, 2018 Key Record Dates |
Last Update Posted: | June 14, 2019 |
Last Verified: | June 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Leukoencephalopathy, Progressive Multifocal Leukoencephalopathies Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Viral Central Nervous System Viral Diseases Virus Diseases Polyomavirus Infections |
DNA Virus Infections Slow Virus Diseases Infectious Encephalitis Encephalitis Central Nervous System Infections Demyelinating Diseases Natalizumab Immunologic Factors Physiological Effects of Drugs |