| Trial registration number
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NCT05075499 |
Full text link
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05075499
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First author
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Anat Achiron, MD, PhD
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Contact
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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anat.achiron@sheba.health.gov.il
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Registration date
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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2021-10-12
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Recruitment status
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
(1) diagnosis of multiple sclerosis (ms) according to 2017 mcdonald criteria. (2) age >=18
years.
(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.
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Exclusion criteria
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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(1) cognitive decline that precludes understanding the study procedures.
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Number of arms
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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3
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Funding
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Sheba Medical Center
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Inclusion age min
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Israel
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Type of patients
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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High risk patients
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Severity scale
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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70
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primary outcome
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose.
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Notes
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "no immunomodulatory treatment", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "under treatment with Teriflunomide", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "under treatment with Alemtuzumab", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]
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