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Trial - NCT05236491


Column Value
Trial registration number NCT05236491
Full text link
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05236491

First author
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Paul R Fortin, MD,MPH,FRCPC

Contact
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

paul.fortin@crchudequebec.ulaval.ca

Registration date
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

2022-02-11

Recruitment status
Last imported at : Aug. 2, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Jan. 19, 2023, 4 a.m.
Source : ClinicalTrials.gov

inclusion criteria diagnosis of a sard (rheumatoid arthritis, systemic lupus erythematosus (sle), juvenile inflammatory arthritis, systemic sclerosis (ssc), idiopathic inflammatory myositis (iim), overlap connective tissue diseases, mixed connective tissue disease, undifferentiated connective tissue diseases, giant-cell arteritis, and the anca-associated vasculitis: granulomatosis with polyangiitis (gpa; formerly known as wegener's granulomatosis), microscopic polyangiitis (mpa), and eosinophilic granulomatosis with polyangiitis (egpa; previously known as churg-strauss syndrome); has received 3 or more doses of an mrna vaccine; age 18 years and older; male or non-pregnant female; rituximab treatment within last 12 months; able to comprehend the study protocol and provide informed consent. exclusion criteria any medical disease or condition that, in the opinion of the site principal investigator or sub-investigator, precludes study participation; significant behavioral disturbances; previous diagnosis of hepatitis b, hepatitis c or hiv; history of hypersensitivity or severe allergic reaction such as anaphylaxis to a component of the vaccine or to a previous vaccine; people who experienced inflammation of the heart or lining of the heart (myocarditis or pericarditis) after a previous dose of an mrna vaccine or protein subunit vaccine.

Exclusion criteria
Last imported at : Aug. 2, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Paul R Fortin

Inclusion age min
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 2, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

287

primary outcome
Last imported at : Aug. 2, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Reactogenicity of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.;Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.

Notes
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Aug. 2, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": " 3 doses of an mRNA vaccine", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " 3 doses of an mRNA vaccine", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "4 doses of an mRNA vaccine", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]