SLENCT07149402
Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus
An observational study of SLE, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
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.
Read the 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
- Keywords
- SLE, IL-33
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marly Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149402
- Sponsor's protocol ID
- SLE Interleukin-33 Levels
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29247993
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07149402
- Acronym / sponsor ID
- SLE Interleukin-33 Levels
- Conditions
- SLE
- Keywords
- SLE, IL-33
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum IL-33 levels
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 29247993Cayrol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IL-33 levels (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.