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

Serum Interleukin-33 (IL-33) Levels and Their Association With Clinical Manifestations in Patients With Systemic Lupus Erythematosus and Lupus Nephritis at Assiut University Hospital

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07149402
Enrollment
150
Registered
2025-09-02
Start date
2026-08-30
Completion date
2027-12-30
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE

Keywords

SLE, IL-33

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum IL-33 levelsBaselineQuantification of serum IL-33 concentrations using a high-sensitivity ELISA kit across three groups: healthy controls, SLE patients without nephritis, and SLE patients with nephritis.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026