Systemic Lupus Erythematous (SLE)LUNETNCT07175610
LUpus Eritematoso Sistemico NETwork and Registry
An observational study of Systemic Lupus Erythematous (SLE), run by Società Italiana di Allergologia, Asma e Immunologia Clinica at 16 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematous (SLE)
- How many people
- 1,500 participants
- Where
- 16 sitesItaly
- Study dates
- 30 Sep 2025to 31 Dec 2035
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with SLE according to the SLICC 2012 and/or ACR/EULAR 2019 classification criteria
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Italy16 sites
SOD Clinica Medica, Dip. Medicina Interna- Ospedali Riuniti Marche-AOU delle Marche
Ancona
Gianluca Moroncini
Medicina Interna Universitaria (Guido Baccelli) Azienda Ospedaliera Policlinico Consorziale
Bari
Angelo Vacca
U.O. di Medicina, Ospedale Civile "Santa Maria della Sapienza"
Battipaglia
Vincenzo Patella
Allergologia e Immunologia Clinica, Azienda Ospedaliero-Universitaria di Cagliari
Cagliari
Stefano Del Giacco
Struttura organizzativa Dipartimentale Complessa Immunologia e Terapie Cellulari, A.O.U. Careggi
Florence
Paola Parronchi
Struttura complessa Allergologia Immunologia Clinica e Reumatologia.Azienda Socio Sanitaria Territoriale di Mantova
Mantua
Maria Teresa Costantino
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare all'IRCCS Ospedale San Raffaele di Milano
Milan, 20132
Lorenzo Dagna
Division of Internal Medicine and Clinical Immunology, Azienda Ospedaliera Universitaria Federico II
Naples
SYNERGO - Institute of Clinical Immunotherapy and Advanced Biological Treatmets-Casa di Cura Pierangeli S.r.l.
Pescara
UO Immunoallergologia clinica, Azienda Ospedaliero Universitaria Pisana
Pisa
Valentina Pucino
UOC di Medicina Interna e Nutrizione Clinica -Policlinico Umberto I
Roma
Reumatologia e Immunologia Clinica, Humanitas Research Hospital
Rozzano
Carlo Francesco Selmi
UOC Clinica Immunologica e Reumatologica, A.O.U. San Giovanni di Dio e Ruggi d'Aragona
Salerno
Massimo Triggiani
SC (U.C.O.) Medicina Clinica Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste
Giacomo Emmi
SCDU Immunologia e Allergologia AO Ordine Mauriziano, University of Turin
Turin, 10128
Luisa Brussino
Simone Negrini
Medicina Interna B - Azienda Ospedaliera Universitaria Integrata
Verona
Simonetta Friso
About this study
Official title: The LUNET Project: the Italian Systemic Erythematous Lupus Network and Registry
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
- Conditions
- Systemic Lupus Erythematous (SLE)
- Keywords
- Systemic Erythematosus Lupus, Connective Tissue Diseases, Autoimmune Diseases, mmune System Diseases, Biologic Therapies
- Medical subject headings
- Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
Number of patients who achieved complete clinical remission or low disease activity
Measured: Every year to ten year
Disease activity
Changes in disease activity (SLEDAI-2k)
Measured: Every year to ten year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2035 (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 Systemic Lupus Erythematous (SLE)Studies 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia Clinica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175610
- Sponsor's protocol ID
- 5
- Acronym
- LUNET
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LUNET Project: the Italian Systemic Erythematous Lupus Network and Registry
- ClinicalTrials.gov ID
- NCT07175610
- Acronym / sponsor ID
- LUNET / 5
- Conditions
- Systemic Lupus Erythematous (SLE)
- Keywords
- Systemic Erythematosus Lupus, Connective Tissue Diseases, Autoimmune Diseases, mmune System Diseases, Biologic Therapies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia ClinicaUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 16 Sep 2025 (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 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with SLE according to the SLICC 2012 and/or ACR/EULAR 2019 classification criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
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
Remission
Time frame: Every year to ten year
Number of patients who achieved complete clinical remission or low disease activity
Disease activity
Time frame: Every year to ten year
Changes in disease activity (SLEDAI-2k)
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 16 Sep 2025.
- Background: PubMed 40943959Mormile 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.
Related trials for Systemic Lupus Erythematous (SLE)
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
RecruitingPhase 1/2
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV)
RecruitingPhase 1
Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematous (SLE)
Not yet recruitingObservational study
Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
Systemic Sclerosis and Systemic Lupus Erythematous
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.
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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematous (SLE), run by Società Italiana di Allergologia, Asma e Immunologia Clinica at 16 sites in Italy.
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 3 inclusion and 1 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Concetta Sirena (+39 02 4969 5358, ricerche@siaaic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: Every year to ten year). The study lists 2 primary outcomes in all. 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 NCT07175610, 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 16 Sep 2025.