COVID-19 Vaccination in Rheumatic Disease Patients

Mayo Clinic

Status and phase: Terminated; Early Phase 1

Conditions: Inflammatory Myositis; Osteoarthritis; Sjogren's Syndrome; Psoriatic Arthritis; Ankylosing Spondylitis; Systemic Lupus Erythematosus; Gout; Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis)

Treatments: Biological: mRNA COVD19 vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04839315

21-000501

Details and patient eligibility

About

The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.

Full description

Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rheumatologist confirmed diagnosis of one of the following diagnoses:
• Systemic lupus erythematosus;
• Sjogren syndrome;
• Inflammatory myositis;
• Psoriatic arthritis;
• Osteoarthritis;
• Gout;
• Ankylosing spondylitis;
• IBD-related arthritis.

Exclusion criteria

• Active infection or untreated malignancy (other than skin cancer) at enrollment.
• Pregnancy

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

mRNA COVID19 vaccines

Other group

Description:

mRNA-based COVID19 vaccines

Treatment:

Biological: mRNA COVD19 vaccine