NCT04426279

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

February 24, 2022

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

June 9, 2020

Last Update Submit

February 7, 2022

Conditions

Sars-CoV2Rheumatoid ArthritisRheumatic Diseases

Keywords

Immunotherapychronic inflammatory rheumatism

Outcome Measures

Primary Outcomes (1)

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

    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.

    At 6 months

Secondary Outcomes (3)

  • To evaluate the frequency of Covid-19 in patients with IRC under IS.

    At 6 months

  • 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

  • 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

Study Arms (1)

patient with chronic inflammatory rheumatism

Other: questionnaire assesment

Interventions

questionnaire assesmentOTHER

15-minute face-to-face questionnaire

patient with chronic inflammatory rheumatism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic inflammatory rheumatic diseases who are immunosuppressed: rheumatoid arthritis/spondylarthritis \[individualized psoriatic spondyloarthritis and rheumatism\]/systemic lupus erythematosus

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lille University Hospital

Lille, France

Location

Related Publications (6)

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PMID: 32109013BACKGROUND

  • Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2. No abstract available.

    PMID: 32241793BACKGROUND

  • Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16. No abstract available.

    PMID: 32309814BACKGROUND

  • Haberman R, Axelrad J, Chen A, Castillo R, Yan D, Izmirly P, Neimann A, Adhikari S, Hudesman D, Scher JU. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York. N Engl J Med. 2020 Jul 2;383(1):85-88. doi: 10.1056/NEJMc2009567. Epub 2020 Apr 29. No abstract available.

    PMID: 32348641BACKGROUND

  • Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.

    PMID: 32311836BACKGROUND

  • Favalli EG, Ingegnoli F, De Lucia O, Cincinelli G, Cimaz R, Caporali R. COVID-19 infection and rheumatoid arthritis: Faraway, so close! Autoimmun Rev. 2020 May;19(5):102523. doi: 10.1016/j.autrev.2020.102523. Epub 2020 Mar 20.

    PMID: 32205186BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidRheumatic Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jean-Guillaume Letarouilly, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 11, 2020

Study Start

August 18, 2020

Primary Completion

March 1, 2021

Study Completion

August 30, 2021

Last Updated

February 24, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)