- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05724940
Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with a highly variable presentation and course. It can affect virtually every organ of the body and many symptoms may be observed. Skin, musculoskeletal, hematologic, and serological involvement are most commonly observed. Some patients show predominately hematologic, renal, or central nervous system manifestations.
Studies have reported that juvenile-onset SLE patients tend to have a more aggressive presentation and course, with higher rates of organ involvement and lower life expectancy than adult-onset SLE patients. Late-onset SLE patients tend to have a more insidious onset of disease and tend to have less major organ involvement and more benign disease course. However, they have a poorer prognosis than patients who developed SLE before the age of 50 years, because of the generally higher frequency of comorbid diseases and higher organ damage, due to aging and longer exposure to ''classical'' vascular risk factors.
Aims of the Study:
To compare clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Study Overview
Status
Conditions
Detailed Description
Methods:
All patients will be subjected to the following:
- Thorough medical history of the patients
Full clinical examination including:
- General examination and vital signs.
- Complete rheumatological examination.
- SLE disease activity index SLEDAI (ref).
- SLICC damage index (ref).
- Routine investigations (complete blood picture, erythrocyte sedimentation rate and liver functions).
Renal investigations:
- Kidney functions
- Urine analysis
- 24 hours protein in urine and/or A/C ratio
- Renal biopsy if indicated.
- ANA test.
- ANA profile for the most common 19 autoantibodies by immunoblot.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria:
- Patients diagnosed as SLE( Systemic lupus erythematosus )according to EULAR / ACE (European League Against Rheumatism /American College of Rheumatology )
- Age juvenile SLE ( Systemic lupus erythematosus )was defined as a diagnosis below the age of 18 years, and those diagnosed between 19 and 50 years of age were classified as adult SLE ( Systemic lupus erythematosus ), late onset SLE was defined as a diagnosis at more than 50 years of age).
- Patients with a disease duration of more than 6 months
Exclusion Criteria:
Exclusion criteria:
- Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease , overlap syndrome or primary Sjogren's syndrome ,but not secondary Sjogren's syndrome or secondary antiphospholipid syndrome .
- Patients who are not willing to be involved in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Time Frame: 1-1-2024
|
|
1-1-2024
|
laboratory differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Time Frame: 1-1-2024
|
|
1-1-2024
|
hematological affection among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Time Frame: 1-1-2024
|
|
1-1-2024
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1 Von Feldt JM. Systemic lupus erythematosus. Recognizing its various presentations. Postgrad Med 1995; 97: 79, 83, 86 passim. 2 Estes D, Christian CL. The natural history of systemic lupus erythematosus by prospective analysis. Medicine (Baltimore) 1971; 50: 85-95. 3 Fessler BJ, Boumpas DT. Severe major organ involvement in systemic lupus erythematosus. Diagnosis and management. Rheum Dis Clin North Am 1995; 21: 81-98. 4 Borchers AT, Naguwa SM, Shoenfeld Y, Gershwin ME. The geoepidemiology of systemic lupus erythematosus. Autoimmun Rev 2010; 9: A277-A287. 5 Ferna´ ndez M, Alarco´ n GS, Calvo-Ale´n J, et al. A multiethnic, multicenter cohort of patients with systemic lupus erythematosus (SLE) as a model for the study of ethnic disparities in SLE. Arthritis Rheum 2007; 57: 576-584. 6 Arbuckle MR, James JA, Dennis GJ, et al. Rapid clinical progression to diagnosis among African-American men with systemic lupus erythematosus. Lupus 2003; 12: 99-106.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-med-22-12-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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