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

Sponsor

Hopital Nord Franche-Comte (Other)

Overall Status

Completed

CT.gov ID

NCT04970550

Collaborator

(none)

150

Enrollment

Location

Actual Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Spondyloarthritis	Other: Non intervention

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Nord Franche-Comté	Trévenans		France	90400

Sponsors and Collaborators

Hopital Nord Franche-Comte

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Nord Franche-Comte

ClinicalTrials.gov Identifier:

NCT04970550

Other Study ID Numbers:

2021-A01013-38

First Posted:

Jul 21, 2021

Last Update Posted:

Mar 16, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hopital Nord Franche-Comte

SARS COV 2 vaccination

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022