NCT04839315

COVID-19 Vaccination in Rheumatic Disease Patients

Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	mRNA COVD19 vaccine	Subjects will receive two doses of mRNA based COVID19 vaccines.

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-02-09
• Completion: 2022-02-09
• First posted: 2021-04-09
• Last updated: 2022-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study