IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage

• Conditions: Systemic Lupus Erythematosus
• Interventions: Diagnostic Test: Serum level of IL-17

• Registration Number: NCT05045417
• Lead Sponsor: Sohag University

Brief Summary

Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus Diverse cytokine abnormalities which common in lupus patients may skew T cells differentiation into IL-17-producing CD4+ and double negative T cells. This could promote the autoimmune process by activation of immune cells \&stimulation of proliferation of B-cell and production of antibody

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-12
• Last Update Submitted: 2021-09-12
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Study Start: 2021-10-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• SLE will be diagnosed according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
• Age ≥ 18 years.
• Patients who are able and willing to give written informed consent

Exclusion Criteria

-Any other autoimmune disease rather than SLE. -

• Systemic diseases
• Malignancy
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases with SLE	Serum level of IL-17	110 patients with SLE will be divided to : * 40 patients with lupus nephritis * 40 patients interstitial lung disease * 30 SLE patients without internal organ affection)
control group	Serum level of IL-17	30 sex and age matched healthy individuals as a control group

Primary Outcome Measures

Name	Time	Method
SLE disease activity index (SLEDAI)	18 Months	• Assessment of the disease activity in the patients will be done by using the SLE disease activity index (SLEDAI). It potentially measures reversible manifestations of the underlying inflammatory disease process. The scale includes24 "weighted" attribute grouped into 9 domains. The final score is the sum of all attributed scores.; * No activity 0; * mild activity: 1-5; * moderate activity: 6- 1 0; * high activity : 1 1 - 1 9; * very high \> 20

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt