Neuron-specific Humoral and Cellular Immune Correlates of Structural and Functional Brain Connectomics in Neuropsychiatric Lupus

NCT ID: NCT05880121

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-04-29

Brief 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. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MRI

Intervention Type: DIAGNOSTIC_TEST

brain 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.

MRI

Intervention Type: DIAGNOSTIC_TEST

brain MRI

Interventions

MRI

brain MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Giannina Gaslini

OTHER

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe A. Ramirez

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

NA NA

Role: primary

ctc.trialstartup@hsr.it

0226437912

Other Identifiers

GR-2021-12372172

Identifier Type: -

Identifier Source: org_study_id