The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients
NCT ID: NCT06313151
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-03-10
2026-03-15
Brief Summary
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Detailed Description
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The patients included in the study will be classified as SLE patient according to 2019 ACR/EULAR classification criteria.
Inclusion criteria:
1. Patient age is above 16 years old
2. Patient is classified as SLE patient according to 2019 ACR/EULAR classification criteria
3. patient with disease duration more than 6 month.
Exclusion criteria:
1. Patient with drug-induced lupus and those with systemic sclerosis or dermatomyositis overlap syndromes .
2. patient with disease duration less than 6 month will be excluded.
Methods:
All patient will be selected randomly and undergo a complete history taking and physical examination, The data will be collected and analyzed as the following:
1. Demographic data: age, gender,sex.
2. Clinical data:
O Age of disease onset ,disease duration, time of disease onset, organs involved , O presence of hypertension, hyperlipidemia, or diabetes, O drugs administration of hydroxychloroquine , azathioprine , cyclophosphamide pulse, cyclosporine, mycophenolate mofetil, prednisolone, and use of pulses of methylprednisolone.
3. disease activity measured by SLEDAI.
Laboratory results:
routine investigations: white cell count, hemoglobin, platelet,serum creatinine, ALT ,AST and urine analysis.
oAntinuclear antibody (ANA) by immunofluorescence and its pattern oANA profile
* Complement C3,C4.
* anticardiolipin antibody (ACA), lupus anticoagulant (LA). O Further investigation will be customized to the patient according to their clinical history and examination like abdominal ultra sound,24 hours urine protein ,glumerular filteration rate ,renal biopsy, x-ray on chest or vertebral colon, CT chest or brain, MRI brain , ECG, echo cardiography.
The organ damage assessment with the SLICC/ACR Damage Index (SDI) contains items that represent permanent, irreversible damage in a lupus patient. Items should be present for at least 6 months with the exception that manifestations such as myocardial infarction and stroke are recorded once they occur. Damage is defined for 12 organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1), and malignancies (0-2). Damage over time can only be stable or increase, theoretically to a maximum of 47 points(6).
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
2. Patient is classified as SLE patient according to 2019 ACR/EULAR classification criteria
3. patient with disease duration more than 6 month.
Exclusion Criteria
2. patient with disease duration less than 6 month will be excluded.
16 Years
60 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Aliaa Abdelhameed
Assistant lecturer
Locations
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Sohag University
Sohag, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Soh-Med-24-02-02MD
Identifier Type: -
Identifier Source: org_study_id
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