Systemic Lupus ErythematosusNCT06796569
Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus and Lupus Nephritis, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- systemic immune inflammatory index
- How many people
- 149 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2024to 20 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients attending in rheumatology outpatient clinic, sohag university hospital
Who may be able to join
- Older than 16 years
- clinical diagnosis of systemic lupus erythematosus
- In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification
Who cannot join
- Patients with other autoimmune rheumatological diseases
- Lymphoproliferative disorders
- malignancies.
- active infections.
- recent history of blood transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Systemic Immune Inflammatory Index With Disease Activity and Lupus Nephritis in Patients With Systemic Lupus Erythematosus
This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Being tested
- systemic immune inflammatory index
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic immune inflammatory indexDiagnostic test
Systemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with systemic lupus and lupus nephritis | this group will include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculatedusing the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. | |
| patients diagnosed with systemic lupus without lupus nephritis | this group will also include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. | |
| healthy control group | this group will also include 30 healthy controls , they will undergo the following: The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. |
What is being measured
The primary outcome is the main question the study is designed to answer.
association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus
This study aims to investigate if there is an association between the systemic immune-inflammation index (SII) and disease activity in patients with systemic lupus erythematosus using SLEDAI(systemic lupus erythematosus disease activity index) as a valid index to compare results with.
The minimum score for the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is 0, and the maximum possible score is 105 with higher scores means higher activity Normal range of systemic imme inflammation index (200_500), with higher values indicateing worse outcome
Measured: baseline
association of systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus
This study aims to investigate the association between the systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus Normal range of systemic imme inflammation index (200_500), with higher values indicateing worse outcome
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start2 Dec 2024
- Primary completion22 Dec 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorouk Ayman Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796569
- Sponsor's protocol ID
- soh-Med-25-1-2MD
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Systemic Immune Inflammatory Index With Disease Activity and Lupus Nephritis in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06796569
- Acronym / sponsor ID
- soh-Med-25-1-2MD
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 28 Jan 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 study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with systemic lupus and lupus nephritis | – | –this group will include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculatedusing the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. |
| patients diagnosed with systemic lupus without lupus nephritis | – | –this group will also include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. |
| healthy control group | – | –this group will also include 30 healthy controls , they will undergo the following: The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients attending in rheumatology outpatient clinic, sohag university hospital
Key inclusion criteria (3 listed)
- Older than 16 years
- clinical diagnosis of systemic lupus erythematosus
- In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification
Key exclusion criteria (5 listed)
- Patients with other autoimmune rheumatological diseases
- Lymphoproliferative disorders
- malignancies.
- active infections.
- recent history of blood transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic immune inflammatory indexSystemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count. | Diagnostic test | – |
Primary outcome
association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus
Time frame: baseline
This study aims to investigate if there is an association between the systemic immune-inflammation index (SII) and disease activity in patients with systemic lupus erythematosus using SLEDAI(systemic lupus erythematosus disease activity index) as a valid index to compare results with. The minimum score for the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is 0, and the maximum possible score is 105 with higher scores means higher activity Normal range of systemic imme inflammation index (200_500), with higher values indicateing worse outcome
association of systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus
Time frame: baseline
This study aims to investigate the association between the systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus Normal range of systemic imme inflammation index (200_500), with higher values indicateing worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Lupus Nephritis, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.