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Status unknownNCT03265236Updated Aug 29, 2017

Diagnostic Value of Anti-MCV in Pts With RA

An observational study in Anti-MCV in Rheamatoid Arthritis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
85
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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 .

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Conditions studied

  • Anti-MCV in Rheamatoid Arthritis

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group1

    Patients with early rheamatoid arthritis

    Diagnostic Test: Anti - modified citrullinate vimentin

  • Group 2

    patients with late rheamatoid arthritis

    Diagnostic Test: Anti - modified citrullinate vimentin

  • Group 3

    Healthy control

Interventions

  • Diagnostic testAnti - modified citrullinate vimentin

    patients with early and late RA

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What researchers measure

Primary outcomes

  1. positive Anti-MCV in RA patient

    early diagnosis of RA patients by Anti-Mcv antibodies

    Time frame: 1 day

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Scott DL. Radiological progression in established rheumatoid arthritis. J Rheumatol Suppl. 2004 Mar;69:55-65. PubMed 15053455 ↗
  • 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. PubMed 25182207 ↗
  • 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. PubMed 17526555 ↗
  • 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.
  • 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. PubMed 25355199 ↗
  • 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. PubMed 19289382 ↗
  • 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. PubMed 6639693 ↗
  • 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. PubMed 20699241 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03265236
Lead sponsor
Assiut University
Responsible party
Jian Hashim Mohammed (Reident doctor, Assiut University) — Principal investigator
First posted
Aug 29, 2017
Start date
Sep 15, 2017 (estimated)
Primary completion
Dec 1, 2018 (estimated)
Completion
Feb 1, 2019 (estimated)
Last update
Aug 29, 2017

Study contacts

dalia A. negm, doctor
Contact
dodonigma@yahoo.com
00201066100185
hanan H. abdel- latiff, professor
Contact
00201002954322
assiut university
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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