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OpenTrials
Completed

NCT Number: NCT04970550

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

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non intervention

Other

Non intervention

Primary outcomes

  1. Determine the desire to be vaccinated against SARS-CoV2

    Time frame: At inclusion

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

Secondary outcomes

  1. Factors associated with the desire for vaccination against SARS-CoV2

    Time frame: At inclusion

    Identify the factors associated with the desire for vaccination against SARS-CoV2 ; determined with a questionnaire

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

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

Acronym: VACCI-RIC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2021
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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