<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/NCT03265236</url>
  </required_header>
  <id_info>
    <org_study_id>diagnostic value of Anti-MCV</org_study_id>
    <nct_id>NCT03265236</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Anti-MCV in Pts With RA</brief_title>
  <official_title>Diagnostic Value of Antibodies Against a Modified Citrullinated Vimentin in Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is to evaluate the diagnostic value of anti-MCV antibodies in rheamatoid&#xD;
      arthritis patients and to correlate its relationtion disease activity and manifestations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by joint&#xD;
      inflammation, subsequent joint destruction leading to loss of joint function, and disability.&#xD;
      Joint erosions develop quickly in 25 % of RA patients during the first 3 months of the&#xD;
      disease and in about 75% of patients during the first 2years .&#xD;
&#xD;
      Early therapeutic intervention with synthetic disease-modifying antirheumatic drugs (sDMARD)&#xD;
      and biological agents that target specific molecules can prevent joint damage and improve the&#xD;
      prognosis of the disease. Since these therapies can have potential toxic effects ,it is very&#xD;
      important that practitioners diagnose early and reliably the disease, especially the more&#xD;
      aggressive forms, in order to select the appropriate treatment for patients.&#xD;
&#xD;
      Early diagnosis of RA can be challenging. During the last 15 years, there has been&#xD;
      significant progress on the pathogenesis of RA with the discovery of antibodies against&#xD;
      citrullinated protein antigens (ACPAs). ACPA production is associated with the HLA-DRB1&#xD;
      shared epitope, cigarette smoking, and periodontitis .&#xD;
&#xD;
      ACPAs have been shown to predict joint damage and are associated with more severe disease and&#xD;
      extra-articular manifestations . In order to better identify RA patients at earlier stages,&#xD;
      new 2010 classification criteria for RA by the American College of Rheumatology&#xD;
      (ACR)/European League against Rheumatism (EULAR) include rheumatoid factor (RF) and ACPAs .&#xD;
&#xD;
      The most common commercial assay for the detection of ACPAs is anti-cyclic citrullinated&#xD;
      peptide (anti-CCP) test, which uses synthetic cyclic citrullinated peptides that mimic RA&#xD;
      epitopes.&#xD;
&#xD;
      Citrullination occurs also in other autoimmune diseases .&#xD;
&#xD;
      . Indeed, histone citrullination may lead to the release of neutrophil extracellular traps,&#xD;
      and juxtaposition of citrullinated histones with infectious pathogens, complement and immune&#xD;
      complexes may compromise tolerance of nuclear autoantigens and promote autoimmunity .&#xD;
&#xD;
      Antibodies to other citrullinated peptides or proteins have been suggested as good candidates&#xD;
      for diagnosing RA.&#xD;
&#xD;
      Anti-MCV antibodies have been recommended to be better diagnostic marker for early arthritis&#xD;
      .&#xD;
&#xD;
      Vimentin is an intermediate filament that is widely expressed by mesenchymal cells and&#xD;
      macrophages and easy to detect in the synovium. Modification of the protein occurs in&#xD;
      macrophages undergoing apoptosis, and antibodies to citrullinatedvimentin may emerge if the&#xD;
      apoptotic material is inadequately cleared .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>positive Anti-MCV in RA patient</measure>
    <time_frame>1 day</time_frame>
    <description>early diagnosis of RA patients by Anti-Mcv antibodies</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Anti-MCV in Rheamatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Group1</arm_group_label>
    <description>Patients with early rheamatoid arthritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>patients with late rheamatoid arthritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Healthy control</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Anti - modified citrullinate vimentin</intervention_name>
    <description>patients with early and late RA</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sixty RA patients attendingAssiut university hospital , and 25 healthy controls were&#xD;
        involved in this study. All patients were previously diagnosed according to the 2010&#xD;
        ACR/EULAR RA classification criteria&#xD;
&#xD;
        The patients and control are divided into:&#xD;
&#xD;
          -  Group I: 30 patients with Early RA&#xD;
&#xD;
          -  Group II:30 patients with Late RA&#xD;
&#xD;
          -  Group III: 25 Healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  . All patients were previously diagnosedaccording to the 2010 ACR/EULAR RA&#xD;
             classification .. with both ( early and late ) rheamatoid arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with other autoimmune disease .&#xD;
&#xD;
          -  patient with renal diseaes .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>assiut university</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>dalia A. negm, doctor</last_name>
    <phone>00201066100185</phone>
    <email>dodonigma@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>hanan H. abdel- latiff, professor</last_name>
    <phone>00201002954322</phone>
  </overall_contact_backup>
  <reference>
    <citation>Scott DL. Radiological progression in established rheumatoid arthritis. J Rheumatol Suppl. 2004 Mar;69:55-65.</citation>
    <PMID>15053455</PMID>
  </reference>
  <reference>
    <citation>Sakkas LI, Bogdanos DP, Katsiari C, Platsoucas CD. Anti-citrullinated peptides as autoantigens in rheumatoid arthritis-relevance to treatment. Autoimmun Rev. 2014 Nov;13(11):1114-20. doi: 10.1016/j.autrev.2014.08.012. Epub 2014 Aug 23.</citation>
    <PMID>25182207</PMID>
  </reference>
  <reference>
    <citation>Syversen SW, Gaarder PI, Goll GL, Odegard S, Haavardsholm EA, Mowinckel P, van der Heijde D, Landewe R, Kvien TK. High anti-cyclic citrullinated peptide levels and an algorithm of four variables predict radiographic progression in patients with rheumatoid arthritis: results from a 10-year longitudinal study. Ann Rheum Dis. 2008 Feb;67(2):212-7. doi: 10.1136/ard.2006.068247. Epub 2007 May 25.</citation>
    <PMID>17526555</PMID>
  </reference>
  <reference>
    <citation>9. Khalifa IA (2013 ), Lotfy AM, Elsayed MA, Abd-Elfattah A, Ashraf Abdelmonem A . Anti-Mutated CitrullinatedVimentin Antibodies in Rheumatoid Arthritis compared with anti-cyclic citrullinated peptides. J Am Sci 9: 160-166.</citation>
  </reference>
  <reference>
    <citation>Muller S, Radic M. Citrullinated Autoantigens: From Diagnostic Markers to Pathogenetic Mechanisms. Clin Rev Allergy Immunol. 2015 Oct;49(2):232-9. doi: 10.1007/s12016-014-8459-2.</citation>
    <PMID>25355199</PMID>
  </reference>
  <reference>
    <citation>Luime JJ, Colin EM, Hazes JM, Lubberts E. Does anti-mutated citrullinated vimentin have additional value as a serological marker in the diagnostic and prognostic investigation of patients with rheumatoid arthritis? A systematic review. Ann Rheum Dis. 2010 Feb;69(2):337-44. doi: 10.1136/ard.2008.103283. Epub 2009 Mar 15.</citation>
    <PMID>19289382</PMID>
  </reference>
  <reference>
    <citation>Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983 Nov;26(11):1346-53. doi: 10.1002/art.1780261107.</citation>
    <PMID>6639693</PMID>
  </reference>
  <reference>
    <citation>Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.</citation>
    <PMID>20699241</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 27, 2017</last_update_submitted>
  <last_update_submitted_qc>August 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Jian Hashim Mohammed</investigator_full_name>
    <investigator_title>Reident doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT03265236
org study id: diagnostic value of Anti-MCV
nct id: NCT03265236
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to evaluate the diagnostic value of anti-MCV antibodies in rheamatoid
      arthritis patients and to correlate its relationtion disease activity and manifestations.
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by joint
      inflammation, subsequent joint destruction leading to loss of joint function, and disability.
      Joint erosions develop quickly in 25 % of RA patients during the first 3 months of the
      disease and in about 75% of patients during the first 2years .

      Early therapeutic intervention with synthetic disease-modifying antirheumatic drugs (sDMARD)
      and biological agents that target specific molecules can prevent joint damage and improve the
      prognosis of the disease. Since these therapies can have potential toxic effects ,it is very
      important that practitioners diagnose early and reliably the disease, especially the more
      aggressive forms, in order to select the appropriate treatment for patients.

      Early diagnosis of RA can be challenging. During the last 15 years, there has been
      significant progress on the pathogenesis of RA with the discovery of antibodies against
      citrullinated protein antigens (ACPAs). ACPA production is associated with the HLA-DRB1
      shared epitope, cigarette smoking, and periodontitis .

      ACPAs have been shown to predict joint damage and are associated with more severe disease and
      extra-articular manifestations . In order to better identify RA patients at earlier stages,
      new 2010 classification criteria for RA by the American College of Rheumatology
      (ACR)/European League against Rheumatism (EULAR) include rheumatoid factor (RF) and ACPAs .

      The most common commercial assay for the detection of ACPAs is anti-cyclic citrullinated
      peptide (anti-CCP) test, which uses synthetic cyclic citrullinated peptides that mimic RA
      epitopes.

      Citrullination occurs also in other autoimmune diseases .

      . Indeed, histone citrullination may lead to the release of neutrophil extracellular traps,
      and juxtaposition of citrullinated histones with infectious pathogens, complement and immune
      complexes may compromise tolerance of nuclear autoantigens and promote autoimmunity .

      Antibodies to other citrullinated peptides or proteins have been suggested as good candidates
      for diagnosing RA.

      Anti-MCV antibodies have been recommended to be better diagnostic marker for early arthritis
      .

      Vimentin is an intermediate filament that is widely expressed by mesenchymal cells and
      macrophages and easy to detect in the synovium. Modification of the protein occurs in
      macrophages undergoing apoptosis, and antibodies to citrullinatedvimentin may emerge if the
      apoptotic material is inadequately cleared .
observational model: Case-Control
time perspective: Prospective
measure: positive Anti-MCV in RA patient
time frame: 1 day
description: early diagnosis of RA patients by Anti-Mcv antibodies
arm group label: Group1
description: Patients with early rheamatoid arthritis
arm group label: Group 2
description: patients with late rheamatoid arthritis
arm group label: Group 3
description: Healthy control
intervention type: Diagnostic Test
intervention name: Anti - modified citrullinate vimentin
description: patients with early and late RA
arm group label: Group 2
arm group label: Group1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
last name: assiut university
role: Principal Investigator
affiliation: Assiut University
last name: dalia A. negm, doctor
phone: 00201066100185
email: dodonigma@yahoo.com
last name: hanan H. abdel- latiff, professor
phone: 00201002954322
citation: Scott DL. Radiological progression in established rheumatoid arthritis. J Rheumatol Suppl. 2004 Mar;69:55-65.
PMID: 15053455
citation: Sakkas LI, Bogdanos DP, Katsiari C, Platsoucas CD. Anti-citrullinated peptides as autoantigens in rheumatoid arthritis-relevance to treatment. Autoimmun Rev. 2014 Nov;13(11):1114-20. doi: 10.1016/j.autrev.2014.08.012. Epub 2014 Aug 23.
PMID: 25182207
citation: Syversen SW, Gaarder PI, Goll GL, Odegard S, Haavardsholm EA, Mowinckel P, van der Heijde D, Landewe R, Kvien TK. High anti-cyclic citrullinated peptide levels and an algorithm of four variables predict radiographic progression in patients with rheumatoid arthritis: results from a 10-year longitudinal study. Ann Rheum Dis. 2008 Feb;67(2):212-7. doi: 10.1136/ard.2006.068247. Epub 2007 May 25.
PMID: 17526555
citation: 9. Khalifa IA (2013 ), Lotfy AM, Elsayed MA, Abd-Elfattah A, Ashraf Abdelmonem A . Anti-Mutated CitrullinatedVimentin Antibodies in Rheumatoid Arthritis compared with anti-cyclic citrullinated peptides. J Am Sci 9: 160-166.
citation: Muller S, Radic M. Citrullinated Autoantigens: From Diagnostic Markers to Pathogenetic Mechanisms. Clin Rev Allergy Immunol. 2015 Oct;49(2):232-9. doi: 10.1007/s12016-014-8459-2.
PMID: 25355199
citation: Luime JJ, Colin EM, Hazes JM, Lubberts E. Does anti-mutated citrullinated vimentin have additional value as a serological marker in the diagnostic and prognostic investigation of patients with rheumatoid arthritis? A systematic review. Ann Rheum Dis. 2010 Feb;69(2):337-44. doi: 10.1136/ard.2008.103283. Epub 2009 Mar 15.
PMID: 19289382
citation: Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983 Nov;26(11):1346-53. doi: 10.1002/art.1780261107.
PMID: 6639693
citation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.
PMID: 20699241
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Jian Hashim Mohammed
investigator title: Reident doctor
mesh term: Arthritis
sharing ipd: No