COVID-19 Vaccination in Rheumatic Disease Patients

NCT04839315 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 21-000501
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Humoral responses towards mRNA COVID-19 vaccines

  We aim to examine SARS-Cov2 specific antibody, and autoantibody generation

  2 weeks to 6 months after second dose of vaccine

Secondary Outcomes (1)

• Cellular immune responses towards mRNA COVID-19 vaccines

  2 weeks to 6 months after second dose of vaccine

Study Arms (1)

mRNA COVID19 vaccines

OTHER

mRNA-based COVID19 vaccines

Biological: mRNA COVD19 vaccine

Interventions

mRNA COVD19 vaccine BIOLOGICAL

Subjects will receive two doses of mRNA based COVID19 vaccines.

mRNA COVID19 vaccines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Sjogren's Syndrome; Arthritis, Psoriatic; Gout; Spondylitis, Ankylosing; Disease; Osteoarthritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Axial Spondyloarthritis; Ankylosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hu Zeng, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: February 15, 2021
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

US (1)