NCT07175610

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2025Dec 2035

First Submitted

Initial submission to the registry

September 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 9, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Systemic Erythematosus LupusConnective Tissue DiseasesAutoimmune Diseasesmmune System DiseasesBiologic Therapies

Outcome Measures

Primary Outcomes (2)

  • Remission

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

    Every year to ten year

  • Disease activity

    Changes in disease activity (SLEDAI-2k)

    Every year to ten year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

SOD Clinica Medica, Dip. Medicina Interna- Ospedali Riuniti Marche-AOU delle Marche

Ancona, Italy

Location

Medicina Interna Universitaria (Guido Baccelli) Azienda Ospedaliera Policlinico Consorziale

Bari, Italy

Location

U.O. di Medicina, Ospedale Civile "Santa Maria della Sapienza"

Battipaglia, Italy

Location

Allergologia e Immunologia Clinica, Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Italy

Location

Struttura organizzativa Dipartimentale Complessa Immunologia e Terapie Cellulari, A.O.U. Careggi

Florence, Italy

Location

Struttura complessa Allergologia Immunologia Clinica e Reumatologia.Azienda Socio Sanitaria Territoriale di Mantova

Mantova, Italy

Location

Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare all'IRCCS Ospedale San Raffaele di Milano

Milan, 20132, Italy

Location

Division of Internal Medicine and Clinical Immunology, Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

SYNERGO - Institute of Clinical Immunotherapy and Advanced Biological Treatmets-Casa di Cura Pierangeli S.r.l.

Pescara, Italy

Location

UO Immunoallergologia clinica, Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

UOC di Medicina Interna e Nutrizione Clinica -Policlinico Umberto I

Roma, Italy

Location

Reumatologia e Immunologia Clinica, Humanitas Research Hospital

Rozzano, Italy

Location

UOC Clinica Immunologica e Reumatologica, A.O.U. San Giovanni di Dio e Ruggi d'Aragona

Salerno, Italy

Location

SC (U.C.O.) Medicina Clinica Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Trieste, Italy

Location

SCDU Immunologia e Allergologia AO Ordine Mauriziano, University of Turin

Turin, 10128, Italy

Location

Medicina Interna B - Azienda Ospedaliera Universitaria Integrata

Verona, Italy

Location

Related Publications (1)

  • 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.

    PMID: 40943959BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, SystemicConnective Tissue DiseasesAutoimmune Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesImmune System Diseases

Study Officials

  • Amato de Paulis

    Division of Internal Medicine and Clinical Immunology, Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 16, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2035

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations