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

ConditionSLE

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The population includes three groups, each with 32 participants for a total of 96 individuals. Inclusion criteria for SLE patients consist of adults aged 18 to 65 years diagnosed per ACR criteria. The lupus nephritis group includes patients with biopsy-confirmed nephritis. Healthy controls are age- and sex-matched individuals without autoimmune or renal diseases. Exclusion criteria contain coexisting autoimmune diseases, chronic infections, malignancies, pregnancy or lactation, end-stage renal disease or dialysis, and those declining consent. This carefully selected population ensures reliable comparisons of IL-33 levels relative to clinical and pathological traits. The sample size was powered to detect medium effect size differences in IL-33 levels among the three groups.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants

are grouped into 3 trial groups

Group A: SLE without Nephritis

Group B: SLE with Lupus Nephritis

Group C: Healthy Controls

Trial outcomes

Primary outcomes

Serum IL-33 levels

Quantification 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.

Time frame

Baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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