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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06294483
• Other study ID #: Soh-Med-24-01-09MS
• Status: Enrolling by invitation
• Start date: January 10, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Intervention

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
• Antinuclear Antibody tests (ANA)
To be tool in diagnosis of SLE
• Rest of ANA profile
As tool of diagnosis of SLE
• C3 and C4 complement level.
As method of detection of acute acivity of SLE
• Anti phospholipid marker
To detect antiphospholipid syndrome if there is sign of thrombosis
• 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
• SLEDAI scores
Is score to detect the activity of disease

Locations

Country	Name	City	State
Egypt	Sohag university hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the hematological indices as (mean platelet volume) of our SLE patient.	Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect mean platelet volume	for 2 weeks after admission of patient in sohag university hospital]
Primary	Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient.	Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect this neutrophil lymphocyte ratio	for 2 weeks after admission of patient in sohag university hospital]
Primary	Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient.	Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect platelet lymphocyte ratio	for 2 weeks after admission of patient in sohag university hospital]
Primary	Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.	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).	for 2 weeks after admission of patient in sohag university hospital]
Primary	Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.	After detection of previous outcome [ disease activity , clinical feature,haematological indices ] we will compare them to detect the correlation between them for every patient	for 2 weeks after admission of patient in sohag university hospital