Rheumatic DiseasesCOVID-RIC3NCT04832022
Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
An observational study of Rheumatic Diseases and SARS-CoV Infection, run by University Hospital, Montpellier at 13 sites in France.
Trial summary
To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases, SARS-CoV Infection, COVID-19
- What is being tested?
- Biological samples
- Type of treatment
- Vaccines
- How many people
- 397 participants
- Where
- 13 sitesFrance
- Study dates
- 7 Apr 2021to 27 Jun 2023
- 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: 1500 CIR patients with or without SARS-COV2 vaccine.
Who may be able to join
- Adult ≥ 18 years old,
- Chronic inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, axial SpA, diagnosed by a rheumatologist
- Having a negative serology for SARS-CoV-2 infection upon inclusion in COVID-RIC1.
- Under csDMARD (conventional synthetic Disease-modifying antirheumatic drug), biotherapy, JAK inhibitor or under symptomatic treatment such as NSAIDs or corticosteroids alone or in combination with a DMARD (Disease-modifying antirheumatic drug)
- Subject having signed a consent
- Affiliated with Social Security
- Having accepted or agreed to be vaccinated against COVID-19 (for vaccine group)
- Having refused to be vaccinated against COVID-19 (for non-vaccine group)
Who cannot join
- Adult patient under legal protection (guardian, curator)
- Patient vaccinated with an anti-SARS-CoV-2 vaccine before the serological test
- Refusal to be vaccinated (for vaccine group)
- Acceptance to be vaccinated (for non-vaccine group))
- Refusal to participate in the study
- Pregnancy and breast feeding
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Brest
Brest, 29200
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
CHU Marseille
Marseille, 13274
Centre hospitalier universitaire de Montpellier
Montpellier, Occitanie, 34295
CHU Nancy
Nancy, 54511
CHU Nantes
Nantes, 44093
CHU Nice
Nice, 06001
CHU Nîmes
Nîmes, 30029
APHP Saint Antoine
Paris, 75012
APHP La pitié Salpêtrière
Paris, 75013
CHU Rouen
Rouen, 76000
CHU Toulouse
Toulouse, 31059
CHU Tours
Tours, 37170
About this study
To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.
Read the detailed description
Longitudinal, comparative, controlled, observational multicenter study based on a cohort of 1500 SARS-CoV-2 seronegative patients with CIRs from the COVID-RIC1 cohort: 750 accepting vaccination and 750 refusing vaccination matched on age (+/-10 years), gender, rheumatism and recruiting center. Schedule: 4 visits over a 12-month period.
An observational routine care study was initiated in 15 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs. The project plans to screen 5000 CIRs patients. The COVID-RIC3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against COVID-19 based on a question asked at the time of their inclusion in COVID-RIC1.
The efficacy and safety of the SARS-CoV2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with CIRs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of "boost" or booster.
- Conditions
- Rheumatic Diseases, SARS-CoV Infection, COVID-19
- Being tested
- Biological samples
- Medical subject headings
- Rheumatic Diseases, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesOther
Serum and plasma samples. At baseline, 3, 6 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Seronegative Chronic Inflammatory Rheumatism (CIR) who accepted vaccination against SARS-CoV2 Receives: Other: Biological samples | |
| Non vaccinated | Seronegative Chronic Inflammatory Rheumatism (CIR) who refused vaccination against SARS-CoV2 Receives: Other: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients
Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in vaccinated chronic inflammatory Rheumatism patients
Measured: At 3 months of the 1st dose of vaccine SARS-COV-2
Proportion of documented COVID-19 infection in non vaccinated chronic inflammatory Rheumatism patients
Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in non vaccinated chronic inflammatory Rheumatism patients
Measured: At 3 months of the 1st dose of vaccine SARS-COV-2
Secondary outcomes (29)
Proportion of documented COVID-19 infection
Proportion of documented COVID-19 infection at 6 months between groups of vaccine and non vaccine patients
Measured: 6 months from 1st vaccine dose
Proportion of documented COVID-19 infection
Proportion of documented COVID-19 infection at 12 months between groups of vaccine and non vaccine patients
Measured: 12 months from 1st vaccine dose
occurrence of infections by type of treatment
occurrence of infections at 6 months by type of treatment
Measured: 6 months from 1st vaccine dose
occurrence of infections by type of treatment
occurrence of infections at 12 months by type of treatment
Measured: 12 months from 1st vaccine dose
occurrence of infections by type of vaccine
occurrence of infections at 3 months by type of vaccine
Measured: 3 months from 1st vaccine dose
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 3 months
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 3 months
Measured: 3 months from 1st vaccine dose
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 6 months
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 6 months
Measured: 6 months from 1st vaccine dose
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 12 months
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 12 months
Measured: 12 months from 1st vaccine dose
Proportion of patients who developed adverse events at 12 months
Proportion of patients who developed adverse events at 12 months
Measured: 12 months from 1st vaccine dose
Proportion of patients with vaccine response
Proportion of patients with vaccine response (SARS-CoV-2 neutralizing antibody IgG and IgM titers) after vaccination against SARS-CoV2 in vaccine patients group
Measured: 3 months from 1st vaccine dose
Proportion of patients with vaccine response
Proportion of patients with vaccine response (SARS-CoV-2 neutralizing antibody IgG and IgM titers) after vaccination against SARS-CoV2 in vaccine patients group
Measured: 6 months from 1st vaccine dose
Proportion of responding patients
Proportion of responding patients with specific IgG in ELISA ≥ titer corresponding to the vaccine protection threshold and neutralizing IgG at 3 months of the first dose of COVID19 vaccine in vaccinated ICRs
Measured: 3 months from 1st vaccine dose
Proportion of responding patients
Proportion of responding patients with specific IgG in ELISA ≥ titer corresponding to the vaccine protection threshold and neutralizing IgG at 3 months of the first dose of COVID19 vaccine in vaccinated ICRs
Measured: 6 months from 1st vaccine dose
Proportion of responding patients
Proportion of responding patients with specific IgG in ELISA ≥ titer corresponding to the vaccine protection threshold and neutralizing IgG at 3 months of the first dose of COVID19 vaccine in vaccinated ICRs
Measured: 12 months from 1st vaccine dose
compare the evolution of disease activity
compare the evolution of disease activity at 3 months in the two groups : change in formula DAS28- CRP (Disease Activity Score C-reactive Protein) between 0 and 3 months for patients with Rheumatoid Arthritis (RA) and patients with psoriatic arthritis.
DAS28 < 2.6: Remission DAS28 >= 2.6 and <= 3.2:Low Disease Activity DAS28 > 3.2 and <= 5.1:Moderate Disease Activity DAS28 > 5.1: High Disease Activity
Measured: 3 months from first vaccine dose
compare the evolution of disease activity
compare the evolution of disease activity at 6 months in the two groups : change in formula DAS28- CRP (Disease Activity Score C-reactive Protein) between 0 and 6 months for patients with Rheumatoid Arthritis (RA) and patients with psoriatic arthritis DAS28 < 2.6: Remission DAS28 >= 2.6 and <= 3.2:Low Disease Activity DAS28 > 3.2 and <= 5.1:Moderate Disease Activity DAS28 > 5.1: High Disease Activity
Measured: 6 months from first vaccine dose
compare the evolution of disease activity
compare the evolution of disease activity at 12 months in the two groups : change in formula DAS28- CRP (Disease Activity Score C-reactive Protein) between 0 and 12 months for patients with Rheumatoid Arthritis (RA) and patients with psoriatic arthritis DAS28 < 2.6: Remission DAS28 >= 2.6 and <= 3.2:Low Disease Activity DAS28 > 3.2 and <= 5.1:Moderate Disease Activity DAS28 > 5.1: High Disease Activity
Measured: 12 months from first vaccine dose
compare the evolution of disease activity
compare the evolution of disease activity at 3 months in the two groups : change in formula ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) between 0 and 6 months for patients with Ankylosing spondylitis (SpA) ASDAS < 1.3: Inactive disease ASDAS >= 1.3 and <= 2.1:Low Disease Activity ASDAS > 2.1 and <= 3.5:Moderate Disease Activity ASDAS > 3.5: High Disease Activity
Measured: 3 months from first vaccine dose
compare the evolution of disease activity
compare the evolution of disease activity at 6 months in the two groups : change in formula ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) between 0 and 6 months for patients with Ankylosing spondylitis (SpA) ASDAS < 1.3: Inactive disease ASDAS >= 1.3 and <= 2.1:Low Disease Activity ASDAS > 2.1 and <= 3.5:Moderate Disease Activity ASDAS > 3.5: High Disease Activity
Measured: 6 months from first vaccine dose
compare the evolution of disease activity
compare the evolution of disease activity at 12 months in the two groups : change in formula ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) between 0 and 12 months for patients with Ankylosing spondylitis (SpA) ASDAS < 1.3: Inactive disease ASDAS >= 1.3 and <= 2.1:Low Disease Activity ASDAS > 2.1 and <= 3.5:Moderate Disease Activity ASDAS > 3.5: High Disease Activity
Measured: 12 months from first vaccine dose
Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: 3 months from first vaccine dose
Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: 6 months from first vaccine dose
Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: 12 months from first vaccine dose
Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
The HADS is a self-administered 14-item scale. Each item is rated on a scale of 0 to 3. Borderline scores make it possible to distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
Measured: 3 months from first vaccine dose
Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
The HADS is a self-administered 14-item scale. Each item is rated on a scale of 0 to 3. Borderline scores make it possible to distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
Measured: 6 months from first vaccine dose
Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
The HADS is a self-administered 14-item scale. Each item is rated on a scale of 0 to 3. Borderline scores make it possible to distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
Measured: 12 months from first vaccine dose
Psychological impact scores: quality of life (EQ5D)
EQ-5D is an European quality of life scale. It is presents as follows: a first part with the questions called "EQ-5D descriptive system", supplemented by a visual analogue scale, called "EQ-5D VAS". It consists of a line of 20 cm, graduated from 0 to 100, where the patient must indicate how he assesses his current state of health, 0 being the worst state possible and 100 the best.
Measured: 3 months from first vaccine dose
Psychological impact scores: quality of life (EQ5D)
EQ-5D is an European quality of life scale. It is presents as follows: a first part with the questions called "EQ-5D descriptive system", supplemented by a visual analogue scale, called "EQ-5D VAS". It consists of a line of 20 cm, graduated from 0 to 100, where the patient must indicate how he assesses his current state of health, 0 being the worst state possible and 100 the best.
Measured: 6 months from first vaccine dose
Psychological impact scores: quality of life (EQ5D)
EQ-5D is an European quality of life scale. It is presents as follows: a first part with the questions called "EQ-5D descriptive system", supplemented by a visual analogue scale, called "EQ-5D VAS". It consists of a line of 20 cm, graduated from 0 to 100, where the patient must indicate how he assesses his current state of health, 0 being the worst state possible and 100 the best.
Measured: 12 months from first vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start7 Apr 2021
- Primary completion21 Jun 2022
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832022
- Sponsor's protocol ID
- RECHMPL21_0021
- Acronym
- COVID-RIC3
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
- ClinicalTrials.gov ID
- NCT04832022
- Acronym / sponsor ID
- COVID-RIC3 / RECHMPL21_0021
- Conditions
- Rheumatic Diseases, SARS-CoV Infection, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 5 Apr 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.
To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.
Detailed description
Longitudinal, comparative, controlled, observational multicenter study based on a cohort of 1500 SARS-CoV-2 seronegative patients with CIRs from the COVID-RIC1 cohort: 750 accepting vaccination and 750 refusing vaccination matched on age (+/-10 years), gender, rheumatism and recruiting center. Schedule: 4 visits over a 12-month period.
An observational routine care study was initiated in 15 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs. The project plans to screen 5000 CIRs patients. The COVID-RIC3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against COVID-19 based on a question asked at the time of their inclusion in COVID-RIC1.
The efficacy and safety of the SARS-CoV2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with CIRs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of "boost" or booster.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | Other: Biological samplesSeronegative Chronic Inflammatory Rheumatism (CIR) who accepted vaccination against SARS-CoV2 |
| Non vaccinated | – | Other: Biological samplesSeronegative Chronic Inflammatory Rheumatism (CIR) who refused vaccination against SARS-CoV2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1500 CIR patients with or without SARS-COV2 vaccine.
Key inclusion criteria (8 listed)
- Adult ≥ 18 years old,
- Chronic inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, axial SpA, diagnosed by a rheumatologist
- Having a negative serology for SARS-CoV-2 infection upon inclusion in COVID-RIC1.
- Under csDMARD (conventional synthetic Disease-modifying antirheumatic drug), biotherapy, JAK inhibitor or under symptomatic treatment such as NSAIDs or corticosteroids alone or in combination with a DMARD (Disease-modifying antirheumatic drug)
- Subject having signed a consent
Key exclusion criteria (6 listed)
- Adult patient under legal protection (guardian, curator)
- Patient vaccinated with an anti-SARS-CoV-2 vaccine before the serological test
- Refusal to be vaccinated (for vaccine group)
- Acceptance to be vaccinated (for non-vaccine group))
- 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, 3, 6 and 12 months | Other | Non vaccinated, Vaccinated |
Primary outcome
Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients
Time frame: At 3 months of the 1st dose of vaccine SARS-COV-2
Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in vaccinated chronic inflammatory Rheumatism patients
Proportion of documented COVID-19 infection in non vaccinated chronic inflammatory Rheumatism patients
Time frame: At 3 months of the 1st dose of vaccine SARS-COV-2
Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in non vaccinated chronic inflammatory Rheumatism patients
29 secondary outcomes
Proportion of documented COVID-19 infection
Time frame: 6 months from 1st vaccine dose
Proportion of documented COVID-19 infection
Time frame: 12 months from 1st vaccine dose
occurrence of infections by type of treatment
Time frame: 6 months from 1st vaccine dose
occurrence of infections by type of treatment
Time frame: 12 months from 1st vaccine dose
occurrence of infections by type of vaccine
Time frame: 3 months from 1st vaccine dose
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 3 months
Time frame: 3 months from 1st vaccine dose
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 6 months
Time frame: 6 months from 1st vaccine dose
Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 12 months
Time frame: 12 months from 1st vaccine dose
Proportion of patients who developed adverse events at 12 months
Time frame: 12 months from 1st vaccine dose
Proportion of patients with vaccine response
Time frame: 3 months from 1st vaccine dose
Proportion of patients with vaccine response
Time frame: 6 months from 1st vaccine dose
Proportion of responding patients
Time frame: 3 months from 1st vaccine dose
Proportion of responding patients
Time frame: 6 months from 1st vaccine dose
Proportion of responding patients
Time frame: 12 months from 1st vaccine dose
compare the evolution of disease activity
Time frame: 3 months from first vaccine dose
compare the evolution of disease activity
Time frame: 6 months from first vaccine dose
compare the evolution of disease activity
Time frame: 12 months from first vaccine dose
compare the evolution of disease activity
Time frame: 3 months from first vaccine dose
compare the evolution of disease activity
Time frame: 6 months from first vaccine dose
compare the evolution of disease activity
Time frame: 12 months from first vaccine dose
Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
Time frame: 3 months from first vaccine dose
Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
Time frame: 6 months from first vaccine dose
Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
Time frame: 12 months from first vaccine dose
Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
Time frame: 3 months from first vaccine dose
Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
Time frame: 6 months from first vaccine dose
Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
Time frame: 12 months from first vaccine dose
Psychological impact scores: quality of life (EQ5D)
Time frame: 3 months from first vaccine dose
Psychological impact scores: quality of life (EQ5D)
Time frame: 6 months from first vaccine dose
Psychological impact scores: quality of life (EQ5D)
Time frame: 12 months from first vaccine dose
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 14 Aug 2023.
Related trials for Rheumatic Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and SARS-CoV Infection, run by University Hospital, Montpellier at 13 sites 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 8 inclusion and 6 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients (time frame: At 3 months of the 1st dose of vaccine SARS-COV-2). 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?
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 14 Aug 2023.