Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab
NCT ID: NCT05075499
Last Updated: 2021-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2021-03-20
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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MS no immunomodulatory treatment
MS patients receiving no immunomodulatory treatment
COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
MS Teriflunomide treatment
MS patients under treatment with Teriflunomide
COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
MS Alemtuzumab treatment
MS patients under treatment with Alemtuzumab
COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
Interventions
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COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
(3) Treatment with Teriflunomide for at least 6 months/or 4 to 18 months after the last course treatment with Alemtuzumab/or untreated.
(4) Signed written informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof. Anat Achiron
Director, Multiple Sclerosis Center
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Study Documents
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Document Type: Study Protocol
Study scientific background. World Health Organization 2021. Background document on mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19.
View DocumentDocument Type: Study Protocol
Aubagio (teriflunomide) \[prescribing information\]. Cambridge (MA): Genzyme Corporation; September 2012.
View DocumentDocument Type: Study Protocol
Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.
View DocumentOther Identifiers
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8182-21 SMC
Identifier Type: -
Identifier Source: org_study_id