| Trial registration number
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NCT04792567 |
Full text link
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04792567
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First author
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Novartis Pharmaceuticals
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Contact
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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novartis.email@novartis.com
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Registration date
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-03-11
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Recruitment status
Last imported at : Sept. 23, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- secondary progressive multiple sclerosis (spms) diagnosis or with relapsing remitting
multiple sclerosis (rrms) at risk to develop spms (at the discretion of the treating
physician)
- on stable ms treatment (siponimod, dimethylfumarate, glatirameracetate, interferon,
teriflunomode or no current treatment)
- no recent treatment changes
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Exclusion criteria
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- prior or current covid-19 disease
- sars-cov-2 antibodies at screening other protocol-defined inclusion/exclusion criteria
may apply
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Number of arms
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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3
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Funding
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Novartis Pharmaceuticals
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Inclusion age min
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Germany
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Type of patients
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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High risk patients
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Severity scale
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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41
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primary outcome
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Percentage of participants achieving seroconversion after receiving a modRNA vaccine
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Notes
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "2;Siponimod - continuous", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Siponimod- interrupted", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Baseline DMTs or no treatment during SARS-CoV-2 mRNA vaccination", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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