Chronic Inflammatory RheumatismCOVIDRIC-2NCT04530682
COVID-19 in Rheumatic Inflammatory Diseases Under Immuno-suppressive Drugs
An observational study of Chronic Inflammatory Rheumatism, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Rheumatism
- What is being tested?
- Biological samples
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2021to 15 Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 200 participants with chronic inflammatory rheumatisms and positive status in the serology for SARS-CoV-2. This population will be compared with a healthy control group from the cohort Covid-Biotoul
Who may be able to join
- Patients with rheumatoid arthritis or spondyloarthritis
- With positive serology for SARS-CoV-2 infection less than 3 months old at the time of inclusion
- Under biotherapy, or conventional synthetic Disease-modifying antirheumatic drugs (csDMARD) or Nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids for at least one month during the year 2020
- Agreeement to participate two years in the study
Who cannot join
- Pregnant or breastfeeding woman
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hopsitalier universitaire de Montpellier
Montpellier, Occitanie, 34295
About this study
Official title: Seroprevalence and Clinical Expression of SARS-CoV-2 Infection in Patients With Chronic Inflammatory Rheumatisms and Impact of Immuno-suppressive Drugs on the Persistence of Anti-SARS-CoV2 Antibodies During Two Years of Follow-up
Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients.
Read the detailed description
Longitudinal, cas-control study, observational multicenter study based on a cohort of 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort.
The follow-up the persistence of SARS-CoV-2 serological status for 2 years in 200 patients with inflammatory rheumatisms compared to matched 100 healthy controls to evaluate the impact of immuno-suppressive therapy will be proposed.
Schedule: 4 visits over a 24-month period.
An observational routine care study was initiated in 16 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs (Covid-RIC-1). The project plans to screen 5000 CIRs patients. The COVID-RIC-2 study will thus be proposed to these pre-screened subjects according to their positive status in the serology for SARS-CoV-2 at the time of their inclusion in COVID-RIC-1.
For the control group, 100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients.
- Conditions
- Chronic Inflammatory Rheumatism
- Being tested
- Biological samples
- Keywords
- COVID-19, SARS-CoV2, Rheumatoid arthritis, Spondyloarthritis, Seroprevalence, Seropersistence
- Medical subject headings
- COVID-19, Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesBiological
Serum and plasma samples. At baseline, 6, 12 and 24 months
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) | 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort. Receives: Biological: Biological samples | |
| Control group | 100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms
Measured: at baseline
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms
Measured: at 6 months after inclusion
Secondary outcomes (6)
To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls.
To assess the maintenance of SARS-CoV-2 seroconversion at 12 months in patients with CIRs compared to non-CIR controls.
Measured: at 12 months after inclusion
To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls
To assess the maintenance of SARS-CoV-2 seroconversion at 24 months in patients with CIRs compared to non-CIR controls.
Measured: at 24 months after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Assess the impact at baseline of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Measured: baseline
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Assess the impact at 6 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Measured: at 6 month after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Assess the impact at 12 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Measured: at 12 month after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Assess the impact at 24 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Measured: at 24 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start5 Mar 2021
- Primary completion23 Jun 2022
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory RheumatismStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Rheumatology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530682
- Sponsor's protocol ID
- RECHMPL20_0409
- Other IDs
- UF8074
- Acronym
- COVIDRIC-2
- Status last verified
- Apr 2024
- First submitted
- 27 Jul 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruyssen-Witrand A, Dimeglio C, Nogue E, Molinary N, Pham T, Gaujoux-Viala C, Miceli-Richard C, Fogel O, Herin F, Martin-Blondel G, Berenbaum F, Breuil V, Chary-Valckenaere I, Confavreux C, Devauchelle-Pensec V, Fautrel B, Flipo RM, Mulleman D, Richez C, Tournadre A, Vittecoq O, Constantin A, Izopet J, Morel J. Comparison of SARS-COV-2 humoral response between rheumatoid arthritis, psoriatic arthritis and spondyloarthritis patients and controls in two unvaccinated cohorts. Clin Exp Rheumatol. 2024 Nov;42(11):2141-2149. doi: 10.55563/clinexprheumatol/48440j. Epub 2024 Oct 17.
PubMed 39436731
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence and Clinical Expression of SARS-CoV-2 Infection in Patients With Chronic Inflammatory Rheumatisms and Impact of Immuno-suppressive Drugs on the Persistence of Anti-SARS-CoV2 Antibodies During Two Years of Follow-up
- ClinicalTrials.gov ID
- NCT04530682
- Acronym / sponsor ID
- COVIDRIC-2 / RECHMPL20_0409
- Conditions
- Chronic Inflammatory Rheumatism
- Keywords
- COVID-19, SARS-CoV2, Rheumatoid arthritis, Spondyloarthritis, Seroprevalence, Seropersistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- French Society of Rheumatology
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 28 Aug 2020 (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.
Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients.
Detailed description
Longitudinal, cas-control study, observational multicenter study based on a cohort of 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort.
The follow-up the persistence of SARS-CoV-2 serological status for 2 years in 200 patients with inflammatory rheumatisms compared to matched 100 healthy controls to evaluate the impact of immuno-suppressive therapy will be proposed.
Schedule: 4 visits over a 24-month period.
An observational routine care study was initiated in 16 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs (Covid-RIC-1). The project plans to screen 5000 CIRs patients. The COVID-RIC-2 study will thus be proposed to these pre-screened subjects according to their positive status in the serology for SARS-CoV-2 at the time of their inclusion in COVID-RIC-1.
For the control group, 100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) | – | Biological: Biological samples200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort. |
| Control group | – | –100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 participants with chronic inflammatory rheumatisms and positive status in the serology for SARS-CoV-2. This population will be compared with a healthy control group from the cohort Covid-Biotoul
Key inclusion criteria (4 listed)
- Patients with rheumatoid arthritis or spondyloarthritis
- With positive serology for SARS-CoV-2 infection less than 3 months old at the time of inclusion
- Under biotherapy, or conventional synthetic Disease-modifying antirheumatic drugs (csDMARD) or Nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids for at least one month during the year 2020
- Agreeement to participate two years in the study
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman
- Refusal to participate in the study
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 |
|---|---|---|
| Biological samplesSerum and plasma samples. At baseline, 6, 12 and 24 months | Biological | SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) |
Primary outcome
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
Time frame: at baseline
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
Time frame: at 6 months after inclusion
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms
6 secondary outcomes
To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls.
Time frame: at 12 months after inclusion
To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls
Time frame: at 24 months after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Time frame: baseline
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Time frame: at 6 month after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Time frame: at 12 month after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
Time frame: at 24 month after 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 12 Jun 2026.
- Results publication: PubMed 39436731Ruyssen-Witrand A, Dimeglio C, Nogue E, Molinary N, Pham T, Gaujoux-Viala C, Miceli-Richard C, Fogel O, Herin F, Martin-Blondel G, Berenbaum F, Breuil V, Chary-Valckenaere I, Confavreux C, Devauchelle-Pensec V, Fautrel B, Flipo RM, Mulleman D, Richez C, Tournadre A, Vittecoq O, Constantin A, Izopet J, Morel J. Comparison of SARS-COV-2 humoral response between rheumatoid arthritis, psoriatic arthritis and spondyloarthritis patients and controls in two unvaccinated cohorts. Clin Exp Rheumatol. 2024 Nov;42(11):2141-2149. doi: 10.55563/clinexprheumatol/48440j. Epub 2024 Oct 17.
Related trials for Chronic Inflammatory Rheumatism
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingObservational study
Evaluation of a Therapeutic Education Program on Self-image in Patients With Chronic Inflammatory Rheumatic Diseases
Chronic Inflammatory Rheumatic Diseases
Not yet recruitingPhase 1
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
Systemic Lupus Erythematosus, Sjögren's Disease
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
Rheumatoid Arthritis
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 Chronic Inflammatory Rheumatism, run by University Hospital, Montpellier 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 12 Jun 2026. 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?
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04530682, which also lists 1 linked publication.
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 12 Jun 2026.