Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313151
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
The 2019 EULARACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
The 2019 EULARACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to investigate if the 2019 EULARACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus SLE and as predictor for prognosis
Detailed Description:
The study will include 200 systemic lupus patient attending Sohag University Hospital from march 2024 to march 2025 in Rheumatology Department
The patients included in the study will be classified as SLE patient according to 2019 ACREULAR classification criteria
Inclusion criteria
1 Patient age is above 16 years old
2 Patient is classified as SLE patient according to 2019 ACREULAR 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 gendersex
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 plateletserum creatinine ALT AST and urine analysis
oAntinuclear antibody ANA by immunofluorescence and its pattern oANA profile
Complement C3C4
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 sound24 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 SLICCACR 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 points6
The patients included in the study will be classified as SLE patient according to 2019 ACREULAR classification criteria
Inclusion criteria
1 Patient age is above 16 years old
2 Patient is classified as SLE patient according to 2019 ACREULAR 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 gendersex
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 plateletserum creatinine ALT AST and urine analysis
oAntinuclear antibody ANA by immunofluorescence and its pattern oANA profile
Complement C3C4
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 sound24 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 SLICCACR 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 points6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None