Clinical trial NCT04530682: COVID-19 in Rheumatic Inflammatory Diseases Under Immuno-suppressive Drugs
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Inflammatory Rheumatism
Keywords: COVID-19
SARS-CoV2
Rheumatoid arthritis
Spondyloarthritis
Seroprevalence
Seropersistence
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: French Society of Rheumatology
First posted: 2020-08-28
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Refusal to participate in the study

Primary outcomes:
measure: Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
timeFrame: at baseline
measure: Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
timeFrame: at 6 months after inclusion
Secondary outcomes:
measure: To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls.
timeFrame: at 12 months after inclusion
measure: To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls
timeFrame: at 24 months after inclusion
measure: Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
timeFrame: baseline
measure: Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
timeFrame: at 6 month after inclusion
measure: Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
timeFrame: at 12 month after inclusion
measure: Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms
timeFrame: at 24 month after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre hopsitalier universitaire de Montpellier
state: Occitanie
Study officials:
References: