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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT03399981 |
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Date of registration:
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09/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
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Scientific title:
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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 |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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80327 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03399981 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Progressive Multifocal Leukoencephalopathy
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Intervention(s)
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Biological: Tysabri
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Primary Outcome(s)
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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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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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Secondary ID(s)
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EUPAS19800
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101MS411
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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