14-3-3 η (Eta) Protein as a Marker of Disease Activity, Severity and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis.
Data Collection
Collected from today forward - ProspectiveArthritis+6
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: September 1, 2021
Actual date on which the first participant was enrolled.All the patients will be interviewed for demographic and clinical data (age, sex, occupation, age at onset of the disease, joints affected, extra-articular features, disease duration, family history and treatment regimen). • Assessment of medical and rheumatologic history. * Careful general and musculoskeletal examination. * Assessment of disease activity will be performed using the Disease Activity Score (DAS28) including 28 tender and swollen joint count, ESR and visual analogue scale. * X-ray both hands and feet * Larsen Score * Assessment of Body Mass Index (BMI) * Laboratory investigations: * Complete blood count (CBC) • Rheumatoid factor (RF) by latex method • Anti citrullinated protein antibodies ACPA by enzyme-linked immunosorbent assay (ELISA) • 14-3-3 η (eta) protein by (ELISA) • Erythrocytic sedimentation rate (ESR) • Quantitative C-reactive protein (CRP) • fasting blood glucose • lipid profile • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) • ECG
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Inclusion criteria: 1. Patients with RA classified according to the revised American College of Rheumatology (ACR)/EULAR RA classification criteria 2010 for RA. 2. Age ≥ 18 years. 3. Patients who are able and willing to give written informed consent. 4. Disease duration more than one year Exclusion Criteria: <!-- --> 1. Any other autoimmune disease rather than RA. 2. Patients with any disease affecting the cardiovascular system other than RA. 3. Patients with known risk factors for atherosclerosis as diabetes, hypertension, hyperlipidemia and obesity.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives