COVID-19 Vaccination in Rheumatic Disease Patients

NCT ID: NCT04839315

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-02-09

Brief Summary

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

Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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mRNA COVID19 vaccines

mRNA-based COVID19 vaccines

Group Type OTHER

mRNA COVD19 vaccine

Intervention Type BIOLOGICAL

Subjects will receive two doses of mRNA based COVID19 vaccines.

Interventions

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mRNA COVD19 vaccine

Subjects will receive two doses of mRNA based COVID19 vaccines.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Hu Zeng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hu Zeng, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-000501

Identifier Type: -

Identifier Source: org_study_id

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