<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426279</url>
  </required_header>
  <id_info>
    <org_study_id>2020_49</org_study_id>
    <secondary_id>2020-A01650-39</secondary_id>
    <nct_id>NCT04426279</nct_id>
  </id_info>
  <brief_title>Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants</brief_title>
  <acronym>CORhum</acronym>
  <official_title>Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A retrospective monocentric study with large active files of patients monitored for&#xD;
      rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main&#xD;
      endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in&#xD;
      conventional units and/or in intensive care and/or deceased). The results will be compared&#xD;
      with those of the general population based on the epidemiological data of Covid-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Number of patients not reached during the inclusion period, end of funding.&#xD;
  </why_stopped>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>analysis of Covid-19-related morbidity and mortality in patients with IRC under IS.</measure>
    <time_frame>At 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the frequency of Covid-19 in patients with IRC under IS.</measure>
    <time_frame>At 6 months</time_frame>
    <description>Diagnosis of Covid-19 either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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).</measure>
    <time_frame>At 6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>At 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">539</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Rheumatic Diseases</condition>
  <arm_group>
    <arm_group_label>patient with chronic inflammatory rheumatism</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire assesment</intervention_name>
    <description>15-minute face-to-face questionnaire</description>
    <arm_group_label>patient with chronic inflammatory rheumatism</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic inflammatory rheumatic diseases who are immunosuppressed: rheumatoid&#xD;
        arthritis/spondylarthritis [individualized psoriatic spondyloarthritis and&#xD;
        rheumatism]/systemic lupus erythematosus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with rheumatoid arthritis on conventional synthetic DMARD (csDMARDs) +/-&#xD;
             biological DMARD (bDMARDs) or targeted synthetic DMARD (tsDMARDs) +/- corticosteroid&#xD;
             therapy meeting ACR/EULAR 2010 classification criteria&#xD;
&#xD;
          -  Patients with spondylarthritison biological DMARD or targeted synthetic DMARD +/-&#xD;
             conventional synthetic DMARD +/- non-steroidal anti-inflammatory drugs meeting ASAS&#xD;
             classification criteria&#xD;
&#xD;
          -  Patients with systemic lupus erythematosus on hydroxychloroquine +/- conventional&#xD;
             synthetic DMARD +/- corticosteroid therapy +/- biological DMARD meeting ACR/EULAR 2019&#xD;
             classification criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Guillaume Letarouilly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lille University Hospital</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>32109013</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32241793</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32309814</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32348641</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32311836</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32205186</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunotherapy</keyword>
  <keyword>chronic inflammatory rheumatism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Fever</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426279
org study id: 2020_49
secondary id: 2020-A01650-39
nct id: NCT04426279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: analysis of Covid-19-related morbidity and mortality in patients with IRC under IS.
time frame: At 6 months
description: 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.
measure: To evaluate the frequency of Covid-19 in patients with IRC under IS.
time frame: At 6 months
description: Diagnosis of Covid-19 either confirmed by diagnostic test (RT-PCR), or by a physician, or by serology.
measure: 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
description: 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).
measure: 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
description: 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.
arm group label: patient with chronic inflammatory rheumatism
intervention type: Other
intervention name: questionnaire assesment
description: 15-minute face-to-face questionnaire
arm group label: patient with chronic inflammatory rheumatism
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Guillaume Letarouilly, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
citation: 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: 32109013
citation: 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: 32241793
citation: 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: 32309814
citation: 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: 32348641
citation: 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: 32311836
citation: 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: 32205186
responsible party type: Sponsor
mesh term: Rheumatic Fever
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases
sharing ipd: No