Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) Clinical Trial

Official title:

Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724940
• Other study ID #: soh-med-22-12-15
• Status: Not yet recruiting
• Start date: March 15, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2023
• Source: Sohag University
• Contact: alaa mo hemdan, assistant
• Phone: 01067302847
• Email: alaahemdan25[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Methods: All patients will be subjected to the following: 1. Thorough medical history of the patients 2. Full clinical examination including: 1. General examination and vital signs. 2. Complete rheumatological examination. 3. SLE disease activity index SLEDAI (ref). 4. SLICC damage index (ref). 3. Routine investigations (complete blood picture, erythrocyte sedimentation rate and liver functions). 4. Renal investigations: 1. Kidney functions 2. Urine analysis 3. 24 hours protein in urine and/or A/C ratio 4. Renal biopsy if indicated. 5. ANA test. 6. ANA profile for the most common 19 autoantibodies by immunoblot.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 1, 2024
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 6 Months to 80 Years

Eligibility

Inclusion Criteria:

Inclusion criteria:

1. Patients diagnosed as SLE( Systemic lupus erythematosus )according to EULAR / ACE (European League Against Rheumatism /American College of Rheumatology )

2. 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).

3. Patients with a disease duration of more than 6 months

Exclusion Criteria:

• Exclusion criteria:

1. 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 .

2. Patients who are not willing to be involved in the study

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus (SLE)

Intervention

Other:
• clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients
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( Systemic Lupus International Collaborating Clinics) 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 (Antinuclear Antibodies)test. ANA profile for the most common 19 autoantibodies by immunoblot.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (1)

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;

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.	SLE disease activity index SLEDAI (ref) to assessment disease activity in patient .; ANA test (antinuclear antibodies ) to assessment auto-antibodies in different age grouped	1-1-2024
Primary	laboratory differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.	Renal biopsy for assessment kidney damage; urine analysis to detect albumin in urine; liver function to detect liver affection	1-1-2024
Primary	hematological affection among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.	cbc complete blood picture to assessment bone marrow affection; erythrocyte sedimentation rate to detect disease activity.	1-1-2024