Rheumatoid ArthritisVACCI-RICNCT04970550
Vaccination Against SARS-Cov2 (COVID-19) in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Hopital Nord Franche-Comte at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis
- What is being tested?
- Non intervention
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: A questionnaire is completed by the patient with the investigator during the medical consultation.
Who may be able to join
- 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.
Who cannot join
- Patients not treated with biotherapy or methotrexate.
- Patients in whom the assessment could not be performed reliably
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccination Against SARS-Cov2 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.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis
- Being tested
- Non intervention
- Keywords
- SARS COV 2 vaccination
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Non intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion
Secondary outcomes (1)
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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970550
- Sponsor's protocol ID
- 2021-A01013-38
- Acronym
- VACCI-RIC
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Against SARS-Cov2 in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.
- ClinicalTrials.gov ID
- NCT04970550
- Acronym / sponsor ID
- VACCI-RIC / 2021-A01013-38
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis
- Keywords
- SARS COV 2 vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A questionnaire is completed by the patient with the investigator during the medical consultation.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients not treated with biotherapy or methotrexate.
- Patients in whom the assessment could not be performed reliably
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionNon intervention | Other | – |
Primary outcome
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
1 secondary outcome
Factors associated with the desire for vaccination against SARS-CoV2
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Hopital Nord Franche-Comte at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the desire to be vaccinated against SARS-CoV2 (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.