Vaccination Against SARS-Cov2 (COVID-19) in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.

NCT04970550 | Completed

• 1 other identifier: 2021-A01013-38
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis and spondyloarthritis (ankylosing spondylitis and psoriatic arthritis mainly) are chronic inflammatory rheumatism (RIC), frequently onset in young adults. The prevalence is respectively 0.3 to 0.8% and 0.4%. or about 600,000 people. The "basic" treatments (DMARDs), essential to control the progression of the disease, are classified into csDMARDs (chemical), the first of which is methotrexate, or bDMARDs (biological). These treatments are immunomodulators and there is an increased risk of severe infection under these therapies. Several vaccinations are therefore recommended by learned societies in patients receiving these treatments, in order to prevent certain infectious risks.In the current pandemic context, the vaccination of these patients against SARS-Cov2 is a major issue in their management and is recommended by the French society of rheumatology. However, many patients express doubts about this vaccination or refuse it. The factors associated with the vaccination will are not known. Better identifying them would make it possible to adapt the information to be given to our patients to promote their adherence.

Conditions

Rheumatoid Arthritis; Spondyloarthritis

Keywords

SARS COV 2 vaccination

Outcome Measures

Primary Outcomes (1)

• Determine the desire to be vaccinated against SARS-CoV2

  Percentage of patients with RIC and treated with DMARDs who favor vaccination against SARS-CoV2 ; determined with a questionnaire

  At inclusion

Secondary Outcomes (1)

• Factors associated with the desire for vaccination against SARS-CoV2

  At inclusion

Interventions

Non intervention OTHER

Non intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A questionnaire is completed by the patient with the investigator during the medical consultation.

You may qualify if:

• Ambulatory patients
• Men or women of any age
• Follow-ups for chronic inflammatory rheumatism such as rheumatoid arthritis or spondyloarthritis
• Treated with methotrexate or biotherapy.

You may not qualify if:

• Patients not treated with biotherapy or methotrexate.
• Patients in whom the assessment could not be performed reliably

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 21, 2021
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2021-07

Locations

FR (1)