TerminatedNot Applicable

SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism

Stopped: The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.

France150 participantsStarted 2020-06-11

Plain-language summary

The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: cases * Patient with spondyloarthritis fulfilling the ASAS criteria * Patients with rheumatoid arthritis fulfilling the ACR/EULAR criteria and * Immunosuppressive therapy: Methotrexate, leflunomide, anti-TNF, Anti-IL6R, abatacept, rituximab, Jak inhibitors (tofacitinib or baricitinib) And * infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan) Controls: * Family cluster member confined to the same location as the index subject * Infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan) Exclusion Criteria: cases and controls * Pregnant woman * Breastfeeding woman * Immunosuppressed subject for members of the familiar cluster of the index subject * Patient with no social security * Patients whose freedom is limited by the judicial or administrative authority * Patients under legal protection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs

Timeframe: up to Day 30

Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs

Timeframe: between Day 30 and Day 90

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: up to Day 30

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: between Day 30 and Day 90

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: 6 Months

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: 12 Months

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Trial details

NCT IDNCT04584541

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-21

View on ClinicalTrials.gov More Spondyloarthritis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs

Timeframe: up to Day 30

Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs

Timeframe: between Day 30 and Day 90

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: up to Day 30

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: between Day 30 and Day 90

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: 6 Months

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

Timeframe: 12 Months

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood