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Not yet recruitingNCT07175610LUNETUpdated Sep 16, 2025

LUpus Eritematoso Sistemico NETwork and Registry

An observational study in Systemic Lupus Erythematous (SLE), sponsored by Società Italiana di Allergologia, Asma e Immunologia Clinica. Not yet recruiting at 16 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Società Italiana di Allergologia, Asma e Immunologia Clinica · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Systemic Lupus Erythematous (SLE)

Keywords

  • Systemic Erythematosus Lupus
  • Connective Tissue Diseases
  • Autoimmune Diseases
  • mmune System Diseases
  • Biologic Therapies
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Società Italiana di Allergologia, Asma e Immunologia Clinica is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with SLE according to the SLICC 2012 and/or ACR/EULAR 2019 classification criteria

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

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Remission

    Number of patients who achieved complete clinical remission or low disease activity

    Time frame: Every year to ten year

  2. Disease activity

    Changes in disease activity (SLEDAI-2k)

    Time frame: Every year to ten year

07

Study locations

16 sites
  • SOD Clinica Medica, Dip. Medicina Interna- Ospedali Riuniti Marche-AOU delle Marche
    Ancona, Italy
    • Gianluca Moroncini · Principal investigator
  • Medicina Interna Universitaria (Guido Baccelli) Azienda Ospedaliera Policlinico Consorziale
    Bari, Italy
    • Angelo Vacca · Principal investigator
  • U.O. di Medicina, Ospedale Civile "Santa Maria della Sapienza"
    Battipaglia, Italy
    • Vincenzo Patella · Principal investigator
  • Allergologia e Immunologia Clinica, Azienda Ospedaliero-Universitaria di Cagliari
    Cagliari, Italy
    • Stefano Del Giacco · Principal investigator
  • Struttura organizzativa Dipartimentale Complessa Immunologia e Terapie Cellulari, A.O.U. Careggi
    Florence, Italy
    • Paola Parronchi · Principal investigator
  • Struttura complessa Allergologia Immunologia Clinica e Reumatologia.Azienda Socio Sanitaria Territoriale di Mantova
    Mantua, Italy
    • Maria Teresa Costantino · Principal investigator
  • Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare all'IRCCS Ospedale San Raffaele di Milano
    Milan, 20132, Italy
    • Lorenzo Dagna · Principal investigator
  • Division of Internal Medicine and Clinical Immunology, Azienda Ospedaliera Universitaria Federico II
    Naples, Italy
  • SYNERGO - Institute of Clinical Immunotherapy and Advanced Biological Treatmets-Casa di Cura Pierangeli S.r.l.
    Pescara, Italy
  • UO Immunoallergologia clinica, Azienda Ospedaliero Universitaria Pisana
    Pisa, Italy
    • Valentina Pucino · Principal investigator
  • UOC di Medicina Interna e Nutrizione Clinica -Policlinico Umberto I
    Roma, Italy
  • Reumatologia e Immunologia Clinica, Humanitas Research Hospital
    Rozzano, Italy
    • Carlo Francesco Selmi · Principal investigator
  • UOC Clinica Immunologica e Reumatologica, A.O.U. San Giovanni di Dio e Ruggi d'Aragona
    Salerno, Italy
    • Massimo Triggiani · Principal investigator
  • SC (U.C.O.) Medicina Clinica Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
    Trieste, Italy
    • Giacomo Emmi · Principal investigator
  • SCDU Immunologia e Allergologia AO Ordine Mauriziano, University of Turin
    Turin, 10128, Italy
    • Luisa Brussino · Principal investigator
    • Simone Negrini · Sub investigator
  • Medicina Interna B - Azienda Ospedaliera Universitaria Integrata
    Verona, Italy
    • Simonetta Friso · Principal investigator
08

References and documents

Publications

  • Mormile I, Brussino L, Canonica GW, Cortini F, Costantino MT, Dagna L, Del Giacco S, Della Casa F, Di Gioacchino M, Emmi G, Moroncini G, Negrini S, Pacella D, Parronchi P, Patella V, Rossi FW, Sirena C, Triggiani M, Vacca A, de Paulis A. The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network. J Clin Med. 2025 Sep 2;14(17):6197. doi: 10.3390/jcm14176197. PubMed 40943959 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07175610
Lead sponsor
Società Italiana di Allergologia, Asma e Immunologia Clinica
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Sep 30, 2025 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Sep 16, 2025

Study contacts

Concetta Sirena
Contact
ricerche@siaaic.org
+39 02 4969 5358
Amato de Paulis
study chair · Division of Internal Medicine and Clinical Immunology, Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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