Systemic Lupus ErythematosusINLESNCT05880121
Neuron-specific Humoral and Cellular Immune Correlates of Structural and Functional Brain Connectomics in Neuropsychiatric Lupus
An observational study of Systemic Lupus Erythematosus, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Systemic lupus erythematosus (SLE) is the prototype systemic autoimmune disease. Neuropsychiatric SLE (NPSLE) is a major cause of morbidity. Its pathophysiology remains unclear and target autoantigens have not yet been identified. Site- specific autoantigen expression might correlate with imaging abnormalities. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- MRI
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to 29 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: see above
Who may be able to join
- Patients with SLE
- Diagnosis of SLE according to the ACR 1997, SLICC 2012 or EULAR/ACR 2019 criteria
- age ≥ 18 years (reference centre)
- age 15-17 years (affiliated centre)
- Healthy subjects
- Charlson's Comorbidity Index=0 and no chronic treatment
- age ≥ 18 years (reference centre)
- age 15-17 years (affiliated centre)
Who cannot join
- History of T-cell neoplasia
- Active B-cell neoplasia or history of B-cell neoplasia of less than five years
- Contraindications to MRI
- Pregnancy
- Ongoing or past treatment with T-depleting agents
- History of brain cancer
Show all 9Show fewer
- History of congenital brain disorders
- Cerebral disorders secondary to trauma, toxins or other metabolic or environmental factors unrelated to SLE according to the Investigator's evaluation
- Any other condition conferring excessive physical and psychological risk to the subject according to the Investigator's opinion
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan
NA NA, 0226437912, ctc.trialstartup@hsr.it
Giuseppe A. Ramirez, MD, PhD
About this study
Systemic lupus erythematosus (SLE) is the prototype systemic autoimmune disease. Neuropsychiatric SLE (NPSLE) is a major cause of morbidity. Its pathophysiology remains unclear and target autoantigens have not yet been identified. Site- specific autoantigen expression might correlate with imaging abnormalities. Based on existing expertise on the use of peptide/protein arrays and on antigen-specific T cell tracking, we plan to identify new fingerprints and targets for NPSLE. SLE patients +/- NPSLE and healthy subjects will undergo advanced magnetic resonance imaging. Three-dimensional data on structural or functional brain architecture will be integrated with brain transcriptome atlases and candidate antigens for autoreactive autoantibodies and T lymphocytes identified and validated. The evidence will add to current knowledge on NPSLE pathophysiology, provide new multimodal diagnostic tools for better patient care and a platform for innovative, personalized treatments.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- MRI
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
brain MRI
| Study group | Role | What they receive |
|---|---|---|
| systemic lupus erythematosus | Patients with SLE according to the 1997 ACR, 2012 SLICC or 2019 EULAR/ACR criteria will undergo MRI along with neuropsychological tests, rheumatological evaluation and blood sample collection at baseline and after at least 12 months or during a new neuropsychiatric manifestation. In case of existing MRI with compatible features, they will be used as baseline studies. Receives: Diagnostic Test: MRI | |
| healthy controls | Subjects with Charlson's Comorbidity Index=0 with no ongoing chronic therapy and no history of immune-mediated disease will undergo a single MRI study, along with neuropsychological tests and blood sample collection. In case of existing MRI with compatible features, no additional studies will be performed in this cohort. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect regional brain functional abnormalities in patients with SLE through advanced magnetic resonance imaging (MRI).
All study subjects will be assessed at baseline through 3T MRI. Repeat MRI will be performed after at least 12 months or in case of new neuropsychiatric events in all patients with SLE. The MRI protocol will include conventional structural sequences (3D fluid-attenuated inversion recovery [FLAIR], 3D T1-weighted inversion recovery prepared gradient echo), advanced structural sequences (diffusion-weighted [DW] pulsed-gradient spin-echo [PSGE] single-shot echo-planar imaging, optimized for an accurate estimation of the neuriteorientation dispersion and density imaging [NODDI] model), and functional MRI sequences acquired in resting-state condition.
Measured: 12 months (extensions allowed for existing images before study onset)
To identify autoantigen-specific circulating antibodies associated with neuropsychiatric morbidity and imaging features in patients with SLE.
High-throughput peptide and/or protein arrays customised according to the data derived from neuroimaging-annotated transcriptome analyses and/or from previous evidence from immune studies performed in a large multicentre cohort of patients with SLE (ZEUS study: NCT02403115) will be used to define candidate antigen targets for autoantibodies. Serum samples will be collected longitudinally at time of clinical evaluation and neuroimaging and analysed by ELISA.
Measured: 12 months (extensions allowed for existing MRI images before study onset)
To correlate antigen-specific CD4+ T-cell dynamics over time with the spectrum of SLE, NPSLE and associated MRI findings.
Major histocompatibility complex (MHC) multimers bound to relevant autoepitopes identified through in silico analyses of data from neuroimaging-annotated transcriptome analyses and/or from previous evidence from immune studies performed in a large multicentre cohort of patients with SLE (ZEUS study: NCT02403115) will be used to detect and track antigen-specific CD4+ T-cells. Further characterisation of T-cells will be performed in terms of differentiation and polarisation. In vitro T-cell reactivity assays with relevant autoepitopes will also be performed
Measured: 12 months (extensions allowed for existing MRI images before study onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start30 Apr 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion29 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Giannina Gaslini
- Responsible party
- Principal investigator, Giuseppe A. Ramirez, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880121
- Sponsor's protocol ID
- GR-2021-12372172
- Acronym
- INLES
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuron-specific Humoral and Cellular Immune Correlates of Structural and Functional Brain Connectomics in Neuropsychiatric Lupus
- ClinicalTrials.gov ID
- NCT05880121
- Acronym / sponsor ID
- INLES / GR-2021-12372172
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Istituto Giannina Gaslini
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 30 May 2023 (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.
Systemic lupus erythematosus (SLE) is the prototype systemic autoimmune disease. Neuropsychiatric SLE (NPSLE) is a major cause of morbidity. Its pathophysiology remains unclear and target autoantigens have not yet been identified. Site- specific autoantigen expression might correlate with imaging abnormalities. Based on existing expertise on the use of peptide/protein arrays and on antigen-specific T cell tracking, we plan to identify new fingerprints and targets for NPSLE. SLE patients +/- NPSLE and healthy subjects will undergo advanced magnetic resonance imaging. Three-dimensional data on structural or functional brain architecture will be integrated with brain transcriptome atlases and candidate antigens for autoreactive autoantibodies and T lymphocytes identified and validated. The evidence will add to current knowledge on NPSLE pathophysiology, provide new multimodal diagnostic tools for better patient care and a platform for innovative, personalized treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic lupus erythematosus | – | Diagnostic Test: MRIPatients with SLE according to the 1997 ACR, 2012 SLICC or 2019 EULAR/ACR criteria will undergo MRI along with neuropsychological tests, rheumatological evaluation and blood sample collection at baseline and after at least 12 months or during a new neuropsychiatric manifestation. In case of existing MRI with compatible features, they will be used as baseline studies. |
| healthy controls | – | Diagnostic Test: MRISubjects with Charlson's Comorbidity Index=0 with no ongoing chronic therapy and no history of immune-mediated disease will undergo a single MRI study, along with neuropsychological tests and blood sample collection. In case of existing MRI with compatible features, no additional studies will be performed in this cohort. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- see above
Key inclusion criteria (8 listed)
- Patients with SLE
- Diagnosis of SLE according to the ACR 1997, SLICC 2012 or EULAR/ACR 2019 criteria
- age ≥ 18 years (reference centre)
- age 15-17 years (affiliated centre)
- Healthy subjects
Key exclusion criteria (9 listed)
- History of T-cell neoplasia
- Active B-cell neoplasia or history of B-cell neoplasia of less than five years
- Contraindications to MRI
- Pregnancy
- Ongoing or past treatment with T-depleting agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIbrain MRI | Diagnostic test | healthy controls, systemic lupus erythematosus |
Primary outcome
To detect regional brain functional abnormalities in patients with SLE through advanced magnetic resonance imaging (MRI).
Time frame: 12 months (extensions allowed for existing images before study onset)
All study subjects will be assessed at baseline through 3T MRI. Repeat MRI will be performed after at least 12 months or in case of new neuropsychiatric events in all patients with SLE. The MRI protocol will include conventional structural sequences (3D fluid-attenuated inversion recovery [FLAIR], 3D T1-weighted inversion recovery prepared gradient echo), advanced structural sequences (diffusion-weighted [DW] pulsed-gradient spin-echo [PSGE] single-shot echo-planar imaging, optimized for an accurate estimation of the neuriteorientation dispersion and density imaging [NODDI] model), and functional MRI sequences acquired in resting-state condition.
To identify autoantigen-specific circulating antibodies associated with neuropsychiatric morbidity and imaging features in patients with SLE.
Time frame: 12 months (extensions allowed for existing MRI images before study onset)
High-throughput peptide and/or protein arrays customised according to the data derived from neuroimaging-annotated transcriptome analyses and/or from previous evidence from immune studies performed in a large multicentre cohort of patients with SLE (ZEUS study: NCT02403115) will be used to define candidate antigen targets for autoantibodies. Serum samples will be collected longitudinally at time of clinical evaluation and neuroimaging and analysed by ELISA.
To correlate antigen-specific CD4+ T-cell dynamics over time with the spectrum of SLE, NPSLE and associated MRI findings.
Time frame: 12 months (extensions allowed for existing MRI images before study onset)
Major histocompatibility complex (MHC) multimers bound to relevant autoepitopes identified through in silico analyses of data from neuroimaging-annotated transcriptome analyses and/or from previous evidence from immune studies performed in a large multicentre cohort of patients with SLE (ZEUS study: NCT02403115) will be used to detect and track antigen-specific CD4+ T-cells. Further characterisation of T-cells will be performed in terms of differentiation and polarisation. In vitro T-cell reactivity assays with relevant autoepitopes will also be performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site 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 Erythematosus, run by IRCCS San Raffaele at 1 site 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect regional brain functional abnormalities in patients with SLE through advanced magnetic resonance imaging (MRI). (time frame: 12 months (extensions allowed for existing images before study onset)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.