| Trial registration number
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NCT04869358 |
Full text link
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04869358
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First author
Last imported at : Aug. 10, 2022, 5:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Contact
Last imported at : Aug. 10, 2022, 5:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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2021-05-03
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Recruitment status
Last imported at : July 13, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : May 8, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- relapsing multiple sclerosis (rms) diagnosis
- eligible for ofatumumab treatment
- willing and eligible to receive sars-cov-2 mrna vaccine
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Exclusion criteria
Last imported at : Aug. 3, 2021, 1:30 p.m.
Source : ClinicalTrials.gov
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- known prior or current covid-19 infection
- previous treatment with btk inhibitor or anti-cd20 therapy other than ofatumumab
other protocol-defined inclusion/exclusion criteria may apply
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Number of arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Novartis Pharmaceuticals
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Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Germany
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Type of patients
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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High risk patients
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Severity scale
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Aug. 10, 2022, 5:30 p.m.
Source : ClinicalTrials.gov
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34
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primary outcome
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Percentage of RMS patients having established SARS-CoV-2-specific T cells after receiving a modRNA vaccine
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Notes
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "vaccines before starting ofatumumab treatment (approx. 1 month later)", "treatment_id": 2293, "treatment_name": "Mrna-1273+ofatumumab", "treatment_type": "Rna based vaccine+monoclonal antibodies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccines while already stable on ofatumumab treatment (at least 4 weeks since first dose)", "treatment_id": 2293, "treatment_name": "Mrna-1273+ofatumumab", "treatment_type": "Rna based vaccine+monoclonal antibodies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}]
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