Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus

NCT ID: NCT07149402

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-08-30
• Study Completion Date: 2027-12-30

Brief Summary

This is a case-control study investigating serum IL-33 levels and their association with clinical manifestations in systemic lupus erythematosus (SLE). The study compares IL-33 levels in three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and healthy controls. The goal is to clarify IL-33's role as a biomarker reflecting disease activity and organ involvement, especially renal pathology.

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with variable clinical presentations, ranging from mild symptoms to life-threatening organ damage. Lupus nephritis, a severe renal manifestation of SLE, significantly contributes to morbidity and mortality. IL-33, a cytokine from the IL-1 family, has been implicated in immune regulation and inflammation, emerging as a potential marker in SLE pathogenesis and progression.

This study systematically evaluates serum IL-33 levels in 96 participants divided into three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and matched healthy controls. The study is conducted over one year at the Rheumatology Department of Assiut University Hospital. It includes clinical assessments, laboratory investigations (including ELISA for IL-33, autoantibody profiles, renal function), renal Doppler ultrasound for nephritis patients, and renal biopsy analyzed using ISN/RPS classification.

By assessing IL-33 levels alongside clinical manifestations, disease activity indices, and histopathological findings, the study aims to define IL-33's diagnostic and prognostic utility in lupus nephritis and overall SLE disease monitoring. Statistical analysis with SPSS includes ANOVA and correlation tests to detect differences and associations.

Conditions

SLE

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

SLE without Nephritis

Patients diagnosed with systemic lupus erythematosus but without evidence of renal involvement. Clinical and laboratory data are collected to correlate IL-33 levels with disease activity excluding renal manifestations.

No interventions assigned to this group

SLE with Lupus Nephritis

Patients with systemic lupus erythematosus and confirmed lupus nephritis via biopsy and clinical parameters. This group undergoes detailed renal Doppler imaging and biopsy assessment to evaluate the relationship of IL-33 with renal involvement.

No interventions assigned to this group

Healthy Controls

Age- and sex-matched healthy individuals without autoimmune or renal disease, serving as baseline comparators for IL-33 serum levels and immune profiles.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 years and older.
• Diagnosed with systemic lupus erythematosus according to the American College of Rheumatology (ACR) criteria.
• For the lupus nephritis group: confirmed diagnosis of lupus nephritis based on clinical, laboratory, and renal biopsy findings.
• For the control group: healthy individuals matched for age and sex, with no history of autoimmune or renal diseases.

Exclusion Criteria

• Patients with other autoimmune diseases. Patients with chronic infections or malignancies. Pregnant or lactating women. Patients with end-stage renal disease (ESRD) or on dialysis. Individuals who refuse to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marly Mamdouh

resident at the Rheumatology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Cayrol C, Girard JP. Interleukin-33 (IL-33): A nuclear cytokine from the IL-1 family. Immunol Rev. 2018 Jan;281(1):154-168. doi: 10.1111/imr.12619.

Reference Type: BACKGROUND

PMID: 29247993 (View on PubMed)

Other Identifiers

SLE Interleukin-33 Levels

Identifier Type: -

Identifier Source: org_study_id