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

Systemic Lupus Erythematosus Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT06294483
• Study type: Observational
• Source: Sohag University
• Status: Enrolling by invitation
• Start date: January 10, 2024
• Completion date: August 30, 2024