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

Rheumatoid Arthritis Clinical Trial

— VACCI-RIC  

Official title:

Vaccination Against SARS-Cov2 in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970550
• Other study ID #: 2021-A01013-38
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2021
• Source: Hopital Nord Franche-Comte
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• Non intervention
Non intervention

Locations

Country	Name	City	State
France	Hôpital Nord Franche-Comté	Trévenans

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Factors associated with the desire for vaccination against SARS-CoV2	Identify the factors associated with the desire for vaccination against SARS-CoV2 ; determined with a questionnaire	At inclusion