COVID-19 Vaccination in Rheumatic Disease Patients

Early Phase 1

Terminated

• Conditions: Inflammatory Myositis; Gout; Osteoarthritis; Systemic Lupus Erythematosus; Sjogren's Syndrome; Psoriatic Arthritis; Ankylosing Spondylitis; Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis)
• Interventions: Biological: mRNA COVD19 vaccine

• Registration Number: NCT04839315
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mRNA COVID19 vaccines	mRNA COVD19 vaccine	mRNA-based COVID19 vaccines

Primary Outcome Measures

Name	Time	Method
Humoral responses towards mRNA COVID-19 vaccines	2 weeks to 6 months after second dose of vaccine	We aim to examine SARS-Cov2 specific antibody, and autoantibody generation

Secondary Outcome Measures

Name	Time	Method
Cellular immune responses towards mRNA COVID-19 vaccines	2 weeks to 6 months after second dose of vaccine	measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States