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Clinical Trials/NCT03224377
NCT03224377UnknownNot Applicable

Diagnostic Utility of Anti-mutated Citrullinated Vimentin Antibodies,Anti Cyclic Citrullinated Peptide Antibodies and Rheumatoid Factor in Rheumatoid Arthritis

Assiut University0 sites80 target enrollmentStarted: October 9, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Primary Endpoint
Anti mutated citrullinated vimentin antibodies

Study Overview

Brief Summary

Rheumatoid arthritis (RA) is a chronic systemic disease affecting primarily the synovium, leading to joint damage and bone destruction(Gravallese E,2002). It is probably the most common autoimmune disease, It is three times more common in women compared to men and usually appears in middle age(poulsom and charles, 2016) .Early diagnosis of RA and its early treatment with disease-modifying anti rheumatic drugs lead to better control and less joint damage .therefore,It is very important to find an acceptable serological marker in order to make an early diagnosis and initiate early treatment to avoid complication and disability ( Orozco C,and Olsen,2006)

Various serum biomarkers are used to diagnose RA, including many autoantibodies. However, only rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) antibodies have wide acceptance (taylor et 2011).

Detailed Description

Antibodies targeting citrullinated proteins are found to be highly specific for the diagnosis of RA (Riedmannet al,2005). Citrullinated antigens are thought to play a pivotal role in the pathogenesis of RA as they are expressed in inflamed joints and, anti-citrullinated protein antibodies are present before clinical disease and are highly specific for RA(van Gaalen et al,2005).

These autoantibodies predict clinical and radiological severity and may be implicated in the pathogenesis of RA ;however, they have a high value in the early diagnosis and early treatment of RA ( Agrawal et al ,2007).

Indeed, it has been demonstrated that anti-citrullinated protein antibodies are produced by plasma cells in the synovial tissue, as concentrations are more than seven fold higher in synovial tissue than in serum (Masson et al,2000).

Rheumatoid factor is not specific to RA, as it is present in patients suffering from other autoimmune and infectious diseases, also found in apparently healthy elderly patients(urusm et al, 2008). Anti- CCP has been shown to be a specific prognostic marker for RA and predict the erosive or non-erosive progression of the disease. Overall, anti-CCP antibodies are a useful marker for aiding the diagnosis of early RA, especially in seronegative(RF negative)( poulsom and charles,2007) Thus, it is a useful tool for the optimal therapeutic management of RA patients.

The diagnosis of RA has been improved by the introduction of other standardized immunoassays for the detection of auto-antibodies against different citrullinated antigens as anti-mutated citrullinated vimentin antibodies .Anti-MCV antibodies have been recommended to be better diagnostic marker for early arthritis (Luime et al,2010). Vimentin is an intermediate filament that is widely expressed by mesenchymal cells &Macrophages and easy to detect in the synovium. Modification of the protein occurs in macrophages undergoing apoptosis, and antibodies to citrullinated vimentin may emerge if the apoptotic material inadequately cleared(Khalifa et ai 2013).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • patients with RA Patients with SLE,Psoriasis and systemic sclerosis as disease control

Exclusion Criteria

  • 1-malignancy patients 2-chronic infection patients as TB and Hepatitis B&C 3_mixed connective tissue diseases

Outcomes

Primary Outcomes

Anti mutated citrullinated vimentin antibodies

Time Frame: at one day of the study

blood sample using Elisa technique

Anti cyclic citrullinated peptide antibodies

Time Frame: at one day of the study

blood sample using Elisa technique

Secondary Outcomes

  • rheumatoid factor (RF) antibody(at one day of the study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayat salah

principal investigator

Assiut University

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