An observational study in Lupus Erythematosus, Systemic, sponsored by Desy Wulandari. Not yet recruiting. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Desy Wulandari · Observational
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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
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.
1,208 studies on the registry are indexed under Lupus Erythematosus, Systemic; 404 are open to participants now.
This study's planned enrollment of 62 is below the median of 150 across 281 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →This is the only study on the registry with Desy Wulandari as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Baseline (at the time of evaluation / sample collection)
Systemic Immune-Inflammation Index (SII)
Calculated as (Platelet count × Neutrophil count) / Lymphocyte count from complete blood count.
Time frame: At the time of enrollment
Serum Ferritin Level
Serum ferritin concentration measured in ng/mL.
Time frame: At the time of enrollment
Neutrophil-to-Lymphocyte Ratio (NLR)
Calculated as Absolute Neutrophil Count / Absolute Lymphocyte Count.
Time frame: At the time of enrollment
Platelet-to-Lymphocyte Ratio (PLR)
Calculated as Absolute Platelet Count / Absolute Lymphocyte Count.
Time frame: At the time of enrollment
Numerical SLEDAI-2K Score
Total numerical disease activity score derived from the SLEDAI-2K index.
Time frame: At the time of enrollment
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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