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LUpus Eritematoso Sistemico NETwork and Registry

The LUNET Project: the Italian Systemic Erythematous Lupus Network and Registry

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07175610
Acronym
LUNET
Enrollment
1500
Registered
2025-09-16
Start date
2025-09-30
Completion date
2035-12-31
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematous (SLE)

Keywords

Systemic Erythematosus Lupus, Connective Tissue Diseases, Autoimmune Diseases, mmune System Diseases, Biologic Therapies

Brief summary

The LUNET Registry is intended to serve as a comprehensive primary data source, capturing real-world longitudinal clinical information, and the heterogeneity of patient presentations that are often underrepresented in traditional clinical trials. Ultimately, the LUNET Registry will help to optimize SLE management in routine clinical practice by enabling the compilation of real-world evidence to inform clinical decision-making and health policy. Patients will be enrolled by secondary and tertiary care centres for SLE across Italy in a real-world clinical set-up.

Detailed description

The LUNET's specific objectives are as follows: * Planning and conducting epidemiological studies to evaluate the incidence and prevalence rates of different clinical manifestations of SLE, and to evaluate short- and long-term outcomes, including survival rates and organ dysfunction, injury, and failure * Promoting multicenter studies that will compare different patient subgroups based on clinical phenotypes and organ involvement, to attain insights regarding disease expression and progression * Describing the profile of patients with lupus nephritis in the national population, to improve guidelines on its systematic and standardized assessment. * Evaluating the presence of central and peripheral nervous system involvement in the national population of patients with SLE, assessing the type, frequency, and severity of neurological symptoms and objective signs, as well as the instrumental techniques used in clinical practice (e.g., Magnetic Resonance Imaging (MRI) * Assessing biomarker data to support early diagnosis and guide treatment choices * Improving screening techniques for early identification of organ damage in SLE patients * Improving early treatment strategies * Tracking adherence and response to therapy * Evaluating the short- and long-term real-life effectiveness and safety of old and novel drugs approved for SLE, overall and in groups of patients with specific phenotypes * Assessing SLE patients' quality of life according to clinical phenotype and treatment approach * Assessing how socioeconomic status impacts patients' access to healthcare and absenteeism in relation to the disease and various therapeutic approaches * Evaluating how different therapeutic strategies impact hospitalization * Assessing the influence of old and novel therapies on fertility, pregnancy, and breastfeeding * Monitoring cardiovascular risk in SLE patients by evaluating the associated comorbidities, prospective development of cardiovascular events, and biomarker levels (e.g., fasting blood glucose, hemoglobin A1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and pro-BNP) * Evaluating bone metabolism in patients with SLE through assessment of laboratory measurements (e.g., vitamin D, calcium, phosphorus, calcinuria, and phosphaturia) and instrumental assessments, such as dual-energy X-ray absorptiometry (DEXA) scans * Monitoring the causes of death among SLE patients

Interventions

None listed

Sponsors

Società Italiana di Allergologia, Asma e Immunologia Clinica
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* age ≥ 18 years; * confirmed SLE diagnosis according to the SLICC 2012 and/or ACR/EULAR 2019 classification criteria; * provision of signed written informed consent prior to participation

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
RemissionEvery year to ten yearNumber of patients who achieved complete clinical remission or low disease activity
Disease activityEvery year to ten yearChanges in disease activity (SLEDAI-2k)

Countries

Italy

Contacts

Primary ContactConcetta Sirena
ricerche@siaaic.org+39 02 4969 5358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026