Status:
UNKNOWN
COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases
Lead Sponsor:
Paul R Fortin
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Rheumatoid Arthritis
Autoimmune Rheumatologic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
People living with Systemic autoimmune rheumatic diseases (SARDs) face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vacci...
Detailed Description
Systemic autoimmune rheumatic diseases (SARDs) include rheumatoid arthritis (RA), systemic lupus (SLE), systemic vasculitis, and related diseases where immune system activity causes widespread inflamm...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT05236491
Start Date
March 9 2022
End Date
December 1 2023
Last Update
January 17 2023
Active Locations (2)
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1
Research Institute - McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
2
Centre de recherche du CHU de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G2