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

Completed

• Conditions: Rheumatoid Arthritis; Spondyloarthritis

• Registration Number: NCT04970550
• Lead Sponsor: Hopital Nord Franche-Comte

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the desire to be vaccinated against SARS-CoV2	At inclusion	Percentage of patients with RIC and treated with DMARDs who favor vaccination against SARS-CoV2 ; determined with a questionnaire

Secondary Outcome Measures

Name	Time	Method
Factors associated with the desire for vaccination against SARS-CoV2	At inclusion	Identify the factors associated with the desire for vaccination against SARS-CoV2 ; determined with a questionnaire

Trial Locations

Locations (1)

Hôpital Nord Franche-Comté; 🇫🇷 Trévenans, France