Diagnostic Value of Anti-MCV in Pts With RA

August 27, 2017 updated by: Jian Hashim Mohammed, Assiut University

Diagnostic Value of Antibodies Against a Modified Citrullinated Vimentin in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1
Patients with early rheamatoid arthritis
Diagnostic test: Anti - modified citrullinate vimentin
patients with early and late RA
Group 2
patients with late rheamatoid arthritis
Diagnostic test: Anti - modified citrullinate vimentin
patients with early and late RA
Group 3
Healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive Anti-MCV in RA patient
Time Frame: 1 day
early diagnosis of RA patients by Anti-Mcv antibodies
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Assiut University, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

August 27, 2017

First Submitted That Met QC Criteria

August 27, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 27, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diagnostic value of Anti-MCV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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