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Diagnostic Value of Anti-MCV in Pts With RA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03265236
Recruitment Status : Unknown
Verified August 2017 by Jian Hashim Mohammed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):
Jian Hashim Mohammed, Assiut University

Tracking Information
First Submitted Date August 27, 2017
First Posted Date August 29, 2017
Last Update Posted Date August 29, 2017
Estimated Study Start Date September 15, 2017
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2017)
positive Anti-MCV in RA patient [ Time Frame: 1 day ]
early diagnosis of RA patients by Anti-Mcv antibodies
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Diagnostic Value of Anti-MCV in Pts With RA
Official Title Diagnostic Value of Antibodies Against a Modified Citrullinated Vimentin in Patients With Rheumatoid Arthritis
Brief Summary 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.
Detailed Description

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 .

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Sixty RA patients attendingAssiut university hospital , and 25 healthy controls were involved in this study. All patients were previously diagnosed according to the 2010 ACR/EULAR RA classification criteria

The patients and control are divided into:

  • Group I: 30 patients with Early RA
  • Group II:30 patients with Late RA
  • Group III: 25 Healthy controls
Condition Anti-MCV in Rheamatoid Arthritis
Intervention Diagnostic Test: Anti - modified citrullinate vimentin
patients with early and late RA
Study Groups/Cohorts
  • Group1
    Patients with early rheamatoid arthritis
    Intervention: Diagnostic Test: Anti - modified citrullinate vimentin
  • Group 2
    patients with late rheamatoid arthritis
    Intervention: Diagnostic Test: Anti - modified citrullinate vimentin
  • Group 3
    Healthy control
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 27, 2017)
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2019
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • . All patients were previously diagnosedaccording to the 2010 ACR/EULAR RA classification .. with both ( early and late ) rheamatoid arthritis

Exclusion Criteria:

  • patients with other autoimmune disease .
  • patient with renal diseaes .
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03265236
Other Study ID Numbers diagnostic value of Anti-MCV
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jian Hashim Mohammed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Principal Investigator: assiut university Assiut University
PRS Account Assiut University
Verification Date August 2017