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Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants (CORhum)

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ClinicalTrials.gov Identifier: NCT04426279
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
A retrospective monocentric study with large active files of patients monitored for rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in conventional units and/or in intensive care and/or deceased). The results will be compared with those of the general population based on the epidemiological data of Covid-19.

Condition or disease Intervention/treatment
Sars-CoV2 Rheumatoid Arthritis Rheumatic Diseases Other: questionnaire assesment

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
patient with chronic inflammatory rheumatism Other: questionnaire assesment
15-minute face-to-face questionnaire




Primary Outcome Measures :
  1. analysis of Covid-19-related morbidity and mortality in patients with IRC under IS. [ Time Frame: At 6 months ]
    the number of patients with severe Covid-19 who were admitted to a conventional unit and/or an ICU and/or deceased, during the Covid-19 epidemic wave (from March to August 2020) among patients with IRC under IS. The diagnosis of Covid-19 is either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology. The results will be compared with those of the general population based on Covid-19 epidemiological data.


Secondary Outcome Measures :
  1. To evaluate the frequency of Covid-19 in patients with IRC under IS. [ Time Frame: At 6 months ]
    Diagnosis of Covid-19 either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology.

  2. To compare the morbidity and mortality of patients with IRC under IS during the Covid-19 epidemic wave (March to August 2020) with the six months prior to this wave (September 2019 to February 2020). [ Time Frame: At 6 months ]
    The number of patients admitted to conventional unit and/or ICU and/or deceased among patients with IRC under IS between the Covid-19 epidemic wave (March to August 2020) and the six-month period preceding it (September to February 2020).

  3. Patients' conduct in relation to their treatment during the epidemic wave (maintenance, modification or discontinuation) and the impact on their disease (loss of remission, flare, corticosteroids requirement and need for switch of DMARD therapy) [ Time Frame: At 6 months ]
    The number of patients who maintained, modified, or discontinued their treatment. Treatment modification will be assessed by the number of weeks of treatment not taken, the number of injections not given, the number of delayed or missed infusions. Among those who have modified or stopped their treatment, the impact on their diseases will be evaluated by the loss of remission, the patient's opinion on the notion of relapse, the increase or initiation of corticosteroid therapy and the substantive change in treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic inflammatory rheumatic diseases who are immunosuppressed: rheumatoid arthritis/spondylarthritis [individualized psoriatic spondyloarthritis and rheumatism]/systemic lupus erythematosus
Criteria

Inclusion Criteria:

  • Patients with rheumatoid arthritis on conventional synthetic DMARD (csDMARDs) +/- biological DMARD (bDMARDs) or targeted synthetic DMARD (tsDMARDs) +/- corticosteroid therapy meeting ACR/EULAR 2010 classification criteria
  • Patients with spondylarthritison biological DMARD or targeted synthetic DMARD +/- conventional synthetic DMARD +/- non-steroidal anti-inflammatory drugs meeting ASAS classification criteria
  • Patients with systemic lupus erythematosus on hydroxychloroquine +/- conventional synthetic DMARD +/- corticosteroid therapy +/- biological DMARD meeting ACR/EULAR 2019 classification criteria

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426279


Contacts
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Contact: Jean-Guillaume Letarouilly, MD 0320446926 ext +33 jeanguillaume.letarouilly@chru-lille.fr

Locations
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France
Lille University Hospital Recruiting
Lille, France
Contact: Jean-Guillaume Letarouilly, DR    +33320446926    jeanguillaume.letarouilly@chru-lille.fr   
Contact: René-Marc Flipo, PR    +33320446926    rene-marc.flipo@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Jean-Guillaume Letarouilly, MD University Hospital, Lille
Publications:

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04426279    
Other Study ID Numbers: EQ2020_04
2020-A01650-39 ( Other Identifier: ID-RCB number,ANSM )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Immunotherapy
chronic inflammatory rheumatism
Additional relevant MeSH terms:
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Rheumatic Fever
Rheumatic Diseases
Collagen Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections