Diagnostic Value of Anti-MCV in Pts With RA

• Conditions: Anti-MCV in Rheamatoid Arthritis
• Interventions: Diagnostic Test: Anti - modified citrullinate vimentin

• Registration Number: NCT03265236
• Lead Sponsor: Assiut University

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 Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-08-27
• Last Update Submitted: 2017-08-27
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29
• Study Start: 2017-09-15
• Primary Completion: 2018-12-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

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Exclusion Criteria

• patients with other autoimmune disease .
• patient with renal diseaes .

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Anti - modified citrullinate vimentin	patients with late rheamatoid arthritis
Group1	Anti - modified citrullinate vimentin	Patients with early rheamatoid arthritis

Primary Outcome Measures

Name	Time	Method
positive Anti-MCV in RA patient	1 day	early diagnosis of RA patients by Anti-Mcv antibodies