Clinical trial

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

Name
RECHMPL20_0409
Description
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.
Trial arms
Trial start
2021-03-05
Estimated PCD
2022-06-23
Trial end
2024-02-15
Status
Completed
Treatment
Biological samples
Serum and plasma samples. At baseline, 6, 12 and 24 months
Arms:
SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs)
Size
163
Primary endpoint
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
at baseline
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms
at 6 months after inclusion
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma samples at baseline. Serum samples at 0, 6, 12 and 24 months.'}, 'enrollmentInfo': {'count': 163, 'type': 'ACTUAL'}}
Updated at
2024-04-30

1 organization

1 product

1 indication