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

Terminated

• Conditions: Sars-CoV2; Rheumatoid Arthritis; Rheumatic Diseases
• Interventions: Other: questionnaire assesment

• Registration Number: NCT04426279
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-08-18
• Status Verified: 2021-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-08-30
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 539

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with chronic inflammatory rheumatism	questionnaire assesment	-

Primary Outcome Measures

Name	Time	Method
analysis of Covid-19-related morbidity and mortality in patients with IRC under IS.	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

Name	Time	Method
To evaluate the frequency of Covid-19 in patients with IRC under IS.	At 6 months	Diagnosis of Covid-19 either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology.
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).	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).
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)	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.

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France