Lupus Erythematosus, SystemicNCT07901634
Association of Inflammatory Biomarkers and Ferritin With Severity of Pediatric Systemic Lupus Erythematosus Patients
An observational study of Lupus Erythematosus, Systemic, run by Desy Wulandari.
Trial summary
The goal of this observational study is to learn about the association of inflammatory biomarkers (SII, NLR, and PLR) and ferritin with disease severity in pediatric systemic lupus erythematosus (pSLE) patients. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2026to 1 Jun 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients (aged 11 to 17 years) diagnosed with systemic lupus erythematosus (pSLE) who attend the pediatric allergy-immunology outpatient clinic or are admitted to the inpatient ward at RSUD Dr. Saiful Anwar, Malang, Indonesia.
Who may be able to join
- Patients aged 11-17 years.
- Diagnosed with systemic lupus erythematosus based on the 2012 SLICC/2019 EULAR/ACR criteria
Who cannot join
- Patients with malignancies.
- Patients with congenital abnormalities.
- Patients who have experienced severe trauma or major surgery within four weeks prior to the examination.
- Patients with liver disease or iron deficiency
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association of SII, NLR, PLR, and Ferritin With SLE Severity Pediatric Patients
The goal of this observational study is to learn about the association of inflammatory biomarkers (SII, NLR, and PLR) and ferritin with disease severity in pediatric systemic lupus erythematosus (pSLE) patients. The main question it aims to answer is:
Are higher levels of SII, NLR, PLR, and ferritin associated with greater disease severity (mild, moderate, severe based on SLEDAI-2K score) in pediatric SLE patients?
Participants diagnosed with pediatric SLE will undergo routine blood tests to measure complete blood counts (NLR, PLR, SII) and serum ferritin, and their disease severity will be assessed using the SLEDAI-2K scoring system
Read the detailed description
Pediatric Systemic Lupus Erythematosus (pSLE) is a chronic autoimmune disorder characterized by innate and adaptive immune activation, leading to autoantibody production, immune complex deposition, and systemic inflammation. Disease activity in pSLE is typically variable and fluctuating, requiring accurate and regular monitoring to optimize immunosuppressive therapy, prevent organ damage accumulation, and avoid treatment toxicity.
Although the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) is widely established for assessing disease activity, its calculation relies on comprehensive clinical evaluations and specialized laboratory parameters (such as anti-dsDNA and complement levels) that may not be routinely available at every clinical encounter. Hematological indices derived from routine complete blood counts specifically the Systemic Immune-Inflammation Index (SII), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR) along with serum ferritin (an acute phase reactant), reflect systemic inflammatory and immune dysregulation. These parameters represent low-cost, rapidly accessible, and widely available potential biomarkers for disease activity.
This observational study aims to evaluate the associations of SII, ferritin, NLR, and PLR with disease severity in pediatric SLE patients. Disease severity will be primarily categorized into mild, moderate, and severe stages based on the SLEDAI-2K score and analyzed as ordinal data, with secondary numerical SLEDAI-2K score analyses.
Because circulating blood cell counts and ferritin concentrations can also be influenced by non-SLE factors such as active infections, Macrophage Activation Syndrome (MAS), nutritional status, underlying hematological disorders, malignancies, and corticosteroid administration these clinical confounders will be rigorously evaluated and considered during statistical interpretation. The observed associations will be evaluated statistically to assess their potential clinical utility as supplementary markers for pSLE disease activity monitoring.
- Conditions
- Lupus Erythematosus, Systemic
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| Pediatric SLE Cohort | Pediatric patients diagnosed with systemic lupus erythematosus (pSLE). All participants undergo clinical and laboratory assessments, including complete blood counts to determine SII, NLR, and PLR, as well as serum ferritin levels. Disease severity is assessed and categorized into mild, moderate, or severe based on the SLEDAI-2K score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric SLE Disease Severity Category
Disease severity categorized into mild, moderate, or severe based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Measured: Baseline (at the time of evaluation / sample collection)
Secondary outcomes (5)
Systemic Immune-Inflammation Index (SII)
Calculated as (Platelet count × Neutrophil count) / Lymphocyte count from complete blood count.
Measured: At the time of enrollment
Serum Ferritin Level
Serum ferritin concentration measured in ng/mL.
Measured: At the time of enrollment
Neutrophil-to-Lymphocyte Ratio (NLR)
Calculated as Absolute Neutrophil Count / Absolute Lymphocyte Count.
Measured: At the time of enrollment
Platelet-to-Lymphocyte Ratio (PLR)
Calculated as Absolute Platelet Count / Absolute Lymphocyte Count.
Measured: At the time of enrollment
Numerical SLEDAI-2K Score
Total numerical disease activity score derived from the SLEDAI-2K index.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion1 Jun 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 Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desy Wulandari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Desy Wulandari, University of Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901634
- Sponsor's protocol ID
- 193/EC/KEPK/07/2025
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD)-including demographic data, clinical characteristics, laboratory biomarker values (SII, serum ferritin, NLR, PLR), and SLEDAI-2K scores-will be made available to researchers who provide a methodologically sound proposal to achieve the aims of the approved protocol.
Publications
Avar-Aydin PO, Brunner HI. Revisiting Childhood-Onset Systemic Lupus Erythematosus. Turk Arch Pediatr. 2024 Jul 1;59(4):336-344. doi: 10.5152/TurkArchPediatr.2024.24097.
PubMed 39102578
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of SII, NLR, PLR, and Ferritin With SLE Severity Pediatric Patients
- ClinicalTrials.gov ID
- NCT07901634
- Acronym / sponsor ID
- 193/EC/KEPK/07/2025
- Conditions
- Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Desy WulandariUniversity, hospital or other
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
The goal of this observational study is to learn about the association of inflammatory biomarkers (SII, NLR, and PLR) and ferritin with disease severity in pediatric systemic lupus erythematosus (pSLE) patients. The main question it aims to answer is:
Are higher levels of SII, NLR, PLR, and ferritin associated with greater disease severity (mild, moderate, severe based on SLEDAI-2K score) in pediatric SLE patients?
Participants diagnosed with pediatric SLE will undergo routine blood tests to measure complete blood counts (NLR, PLR, SII) and serum ferritin, and their disease severity will be assessed using the SLEDAI-2K scoring system
Detailed description
Pediatric Systemic Lupus Erythematosus (pSLE) is a chronic autoimmune disorder characterized by innate and adaptive immune activation, leading to autoantibody production, immune complex deposition, and systemic inflammation. Disease activity in pSLE is typically variable and fluctuating, requiring accurate and regular monitoring to optimize immunosuppressive therapy, prevent organ damage accumulation, and avoid treatment toxicity.
Although the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) is widely established for assessing disease activity, its calculation relies on comprehensive clinical evaluations and specialized laboratory parameters (such as anti-dsDNA and complement levels) that may not be routinely available at every clinical encounter. Hematological indices derived from routine complete blood counts specifically the Systemic Immune-Inflammation Index (SII), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR) along with serum ferritin (an acute phase reactant), reflect systemic inflammatory and immune dysregulation. These parameters represent low-cost, rapidly accessible, and widely available potential biomarkers for disease activity.
This observational study aims to evaluate the associations of SII, ferritin, NLR, and PLR with disease severity in pediatric SLE patients. Disease severity will be primarily categorized into mild, moderate, and severe stages based on the SLEDAI-2K score and analyzed as ordinal data, with secondary numerical SLEDAI-2K score analyses.
Because circulating blood cell counts and ferritin concentrations can also be influenced by non-SLE factors such as active infections, Macrophage Activation Syndrome (MAS), nutritional status, underlying hematological disorders, malignancies, and corticosteroid administration these clinical confounders will be rigorously evaluated and considered during statistical interpretation. The observed associations will be evaluated statistically to assess their potential clinical utility as supplementary markers for pSLE disease activity monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric SLE Cohort | – | –Pediatric patients diagnosed with systemic lupus erythematosus (pSLE). All participants undergo clinical and laboratory assessments, including complete blood counts to determine SII, NLR, and PLR, as well as serum ferritin levels. Disease severity is assessed and categorized into mild, moderate, or severe based on the SLEDAI-2K score |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients (aged 11 to 17 years) diagnosed with systemic lupus erythematosus (pSLE) who attend the pediatric allergy-immunology outpatient clinic or are admitted to the inpatient ward at RSUD Dr. Saiful Anwar, Malang, Indonesia.
Key inclusion criteria (2 listed)
- Patients aged 11-17 years.
- Diagnosed with systemic lupus erythematosus based on the 2012 SLICC/2019 EULAR/ACR criteria
Key exclusion criteria (4 listed)
- Patients with malignancies.
- Patients with congenital abnormalities.
- Patients who have experienced severe trauma or major surgery within four weeks prior to the examination.
- Patients with liver disease or iron deficiency
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
Pediatric SLE Disease Severity Category
Time frame: Baseline (at the time of evaluation / sample collection)
Disease severity categorized into mild, moderate, or severe based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
5 secondary outcomes
Systemic Immune-Inflammation Index (SII)
Time frame: At the time of enrollment
Serum Ferritin Level
Time frame: At the time of enrollment
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: At the time of enrollment
Platelet-to-Lymphocyte Ratio (PLR)
Time frame: At the time of enrollment
Numerical SLEDAI-2K Score
Time frame: At the time of enrollment
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 28 Oct 2026.
- Background: PubMed 39102578Avar-Aydin PO, Brunner HI. Revisiting Childhood-Onset Systemic Lupus Erythematosus. Turk Arch Pediatr. 2024 Jul 1;59(4):336-344. doi: 10.5152/TurkArchPediatr.2024.24097.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD)-including demographic data, clinical characteristics, laboratory biomarker values (SII, serum ferritin, NLR, PLR), and SLEDAI-2K scores-will be made available to researchers who provide a methodologically sound proposal to achieve the aims of the approved protocol.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by Desy Wulandari.
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 2 inclusion and 4 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 28 Oct 2026. 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?
Contact Desy Wulandari, Pediatrician (+62 81217575207, desywulandari@ub.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric SLE Disease Severity Category (time frame: Baseline (at the time of evaluation / sample collection)). 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 NCT07901634, 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 28 Oct 2026.