| Trial registration number
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EUCTR2021-001414-10-NL |
Full text link
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001414-10/NL
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First author
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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University Medical Center Groningen - Postdoctoral researcher
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Contact
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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g.m.p.j.verstappen@umcg.nl
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Registration date
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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2021-03-24
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Recruitment status
Last imported at : Dec. 16, 2022, midnight
Source : EU Clinical Trials Register
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Completed
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Study design
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Non-randomized
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Design
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Single group assignment
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Masking
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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single-center
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Study aim
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Age 18-75 years
Written informed consent
Fulfilment of 2016 ACR-EULAR criteria (for pSS patients)
Female sex (for healthy volunteers)
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Exclusion criteria
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Confirmed SARS-CoV-2 infection (current or previous)
Women who are pregnant (self-reported, participants will be asked -when in doubt- to perform a pregnancy test before study entry)
Current use of prednisone >10mg/day, conventional DMARDs (except hydroxychloroquine) or biological DMARDS. Previous use of DMARDs ≥6 months before inclusion (≥12 months for rituximab) is allowed.
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Number of arms
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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3
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Funding
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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University Medical Center Groningen
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Inclusion age min
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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75
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Countries
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Netherlands
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Type of patients
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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High risk patients
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Severity scale
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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180
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primary outcome
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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The absolute difference in protective antibody titers against SARS-CoV-2 on day 28 after the second vaccination between patients with pSS and healthy controls.
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Notes
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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nan
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Phase
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : April 21, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "2", "treatment_id": 339, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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