An observational study in Rheumatoid Arthritis, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Assiut University · Observational
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).
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).
A significant correlation has been established between anti-MCV antibodies titers and both the severity of RA and the disease-activity score (DAS28) ,anti-MCV-positive patients exhibited significantly lower reduction in disease activity and a greater number of swollen joints. Thus, it appears that, anti-MCV antibodies may have the advantage of correlating better with disease activity and patient outcome(Al-Shukaili et al,2012)
The anti-mutated citrullinated vimentin antibody ELISA isa recently developed assay for the detection of IgG antibodies to a vimentin-based peptide .Anti-MCV antibody has been reported with a sensitivity of 65-82%, specificity of 80-95%.Anti-MCV antibody concentrations have also been reported as correlating with disease activity score , prognostic for disease severity, and being treatment sensitive, enabling their use in monitoring response to therapy (Bang et al,2006)
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 80 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Blood sampling using ELisa technique
Also known as: anti cyclic citrullinated peptide antibodies
Anti mutated citrullinated vimentin antibodies
blood sample using Elisa technique
Time frame: at one day of the study
Anti cyclic citrullinated peptide antibodies
blood sample using Elisa technique
Time frame: at one day of the study
rheumatoid factor (RF) antibody
blood sampling
Time frame: at one day of the study
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2017; primary completion for Oct 2018, 12 months later.
Of 196 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 96. This study's planned 12 months is below that.
Counting every sponsor, half of 317 studies reached it within 47 months; a quarter within 24 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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