NCT03224377

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 19, 2017

Last Update Submit

July 19, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Anti mutated citrullinated vimentin antibodies

    blood sample using Elisa technique

    at one day of the study

  • Anti cyclic citrullinated peptide antibodies

    blood sample using Elisa technique

    at one day of the study

Secondary Outcomes (1)

  • rheumatoid factor (RF) antibody

    at one day of the study

Study Arms (2)

rheumatoid arthritis patients

Complete blood count Esr Crp Liver function test Kidney function test Hepatitis markers Rheumatoid factor Urine analysis Anti cyclic citrullinated peptide antibodies Anti mutated citrullinated vimentin antibodies

Diagnostic Test: anti mutated citrullinated vimentin antibodies

healthy control

Complete blood count Esr Crp Liver function test Kidney function test Hepatitis markers Rheumatoid factor Urine analysis Anti cyclic citrullinated peptide antibodies Anti mutated citrullinated vimentin antibodies

Diagnostic Test: anti mutated citrullinated vimentin antibodies

Interventions

anti mutated citrullinated vimentin antibodiesDIAGNOSTIC_TEST

Blood sampling using ELisa technique

Also known as: anti cyclic citrullinated peptide antibodies
healthy controlrheumatoid arthritis patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

80 patient with different rheumatic diseases,40 patients with RA and 20 patients with other rheumatic diseases (disease control),beside 20 healthy subject age and sex matched with the patients as healthy control. The patients will be recruited from Internal medicine department and Rheumatology Out patient clinics of Assuit University Hospital . All patients will be diagnosed as RA according to 2010 ACR/EULAR rheumatoid arthritis classification criteria.All patients will under go detailed history and compelete examination Generalized muscloskeletal examination and local clinical examination of affected joints e.g number of swollen joints ,number of tender joints,assessment of disease activity and functional disability by 28 joint disease activity score calculator (DAS28).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Agrawal S, Misra R, Aggarwal A. Autoantibodies in rheumatoid arthritis: association with severity of disease in established RA. Clin Rheumatol. 2007 Feb;26(2):201-4. doi: 10.1007/s10067-006-0275-5. Epub 2006 Mar 30.

    PMID: 16572283RESULT

  • Hayem G, Chazerain P, Combe B, Elias A, Haim T, Nicaise P, Benali K, Eliaou JF, Kahn MF, Sany J, Meyer O. Anti-Sa antibody is an accurate diagnostic and prognostic marker in adult rheumatoid arthritis. J Rheumatol. 1999 Jan;26(1):7-13.

    PMID: 9918234RESULT

  • Orozco C, Olsen NJ. Identification of patients with early rheumatoid arthritis: challenges and future directions. Clin Dev Immunol. 2006 Jun-Dec;13(2-4):295-7. doi: 10.1080/17402520600877794.

    PMID: 17162371RESULT

  • Poulsom H, Charles PJ. Antibodies to citrullinated vimentin are a specific and sensitive marker for the diagnosis of rheumatoid arthritis. Clin Rev Allergy Immunol. 2008 Feb;34(1):4-10. doi: 10.1007/s12016-007-8016-3.

    PMID: 18270850RESULT

  • Riedemann JP, Munoz S, Kavanaugh A. The use of second generation anti-CCP antibody (anti-CCP2) testing in rheumatoid arthritis--a systematic review. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S69-76.

    PMID: 16273788RESULT

  • Ursum J, Nielen MM, van Schaardenburg D, van der Horst AR, van de Stadt RJ, Dijkmans BA, Hamann D. Antibodies to mutated citrullinated vimentin and disease activity score in early arthritis: a cohort study. Arthritis Res Ther. 2008;10(1):R12. doi: 10.1186/ar2362. Epub 2008 Jan 28.

    PMID: 18226202RESULT

  • van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845-50. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-K.

    PMID: 9778226RESULT

  • Vossenaar ER, Radstake TR, van der Heijden A, van Mansum MA, Dieteren C, de Rooij DJ, Barrera P, Zendman AJ, van Venrooij WJ. Expression and activity of citrullinating peptidylarginine deiminase enzymes in monocytes and macrophages. Ann Rheum Dis. 2004 Apr;63(4):373-81. doi: 10.1136/ard.2003.012211.

    PMID: 15020330RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and serum sampling separated by centrifugation

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Nabawia M Tawfik, MD

CONTACT

0122 397 1418nabawia.hassan@med.au.edu.eg

Hanan sh Muhammed, MD

CONTACT

0100 503 5006dr_hanansharaf@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

October 9, 2017

Primary Completion

October 9, 2018

Study Completion

February 1, 2019

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share