NCT06294483

Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.

Comparison of Clinical Features, Hematological Indices and Disease Activity Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The present study aims to: Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus. Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.

Detailed description

This is a cross sectional study, patients with SLE will be gathered from the Internal medicine department and Rheumatology and Immunology outpatient clinic in Sohag university hospital. All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. In this study, 100 SLE patients will be classified into two groups: Group A: early onset SLE (age at diagnosis \< 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50 Data collection procedure: The following clinical data will be collected: Clinical assessment: Name, age, gender, smoker or ex-smoker or non-smoker, blood pressure and body mass index. Clinical manifestations as: Malar rash. Discoid rash. Photosensitivity. Mucocutaneous or oral ulcer. Alopecia. Raynaud's phenomena. History of deep venous thrombosis. Cutaneous vasculitis. Fever. Lupus nephritis. Arthritis. Myositis. Secondary antiphospholipid syndrome. Serositis. Pleural effusion. Renal manifestations (puffiness and lower limb edema). Neurological (headache, seizers, psychosis and Disturbed conscious level) Hematological manifestations: Thrombocytopenia (bleeding tendency) Anemia and Hemolytic anemia (anemic manifestation). Hypertension. Diabetes mellitus. Previous coronary event or Peripheral vascular disease. Laboratory assessment: 1. CBC with differential WBCs count. 2. Antinuclear Antibody tests (ANA). 3. Anti-double-stranded DNA (ds DNA). 4. Anti-Sm. 5. C3 and C4 complement level. 6. Serum creatinine level. 7. Anti phospholipid marker (if needed). Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20). The present study aims to: Compare clinical features, and disease activity as SLEDAI score between the early-onset and late-onset patients with systemic lupus erythematosus. Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity Duration of study: Six months after approval of the protocol by Medical Research Ethics Committee of Sohag faculty of medicine. Inclusion criteria: All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Exclusion Criteria: Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CBC	Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
DIAGNOSTIC_TEST	Antinuclear Antibody tests (ANA)	To be tool in diagnosis of SLE
DIAGNOSTIC_TEST	Rest of ANA profile	As tool of diagnosis of SLE
DIAGNOSTIC_TEST	C3 and C4 complement level.	As method of detection of acute acivity of SLE
DIAGNOSTIC_TEST	Anti phospholipid marker	To detect antiphospholipid syndrome if there is sign of thrombosis
DIAGNOSTIC_TEST	Serum creatinine and Alb/create ratio	To detct complication of disease on kidney
OTHER	2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.	Is criteria of diagnosis of SLE
OTHER	SLEDAI scores	Is score to detect the activity of disease

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-07-30
• Completion: 2024-08-30
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Egypt