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

Launched by IRCCS SAN RAFFAELE · May 18, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: Understanding Brain Health in Lupus Patients**

This clinical trial is focused on studying how systemic lupus erythematosus (SLE), particularly when it affects the brain (known as neuropsychiatric SLE or NPSLE), impacts brain structure and function. Researchers want to uncover specific markers in the blood and immune responses that might help explain brain changes seen in SLE patients. By using advanced brain imaging techniques, the study aims to connect these changes to the immune system's activity, ultimately helping to improve diagnosis and treatment for those living with NPSLE.

If you're considering participating in this trial, you should be at least 15 years old, have a diagnosis of SLE, and meet certain health requirements (like having no serious ongoing health issues). Healthy individuals who meet the same age criteria are also eligible to participate. During the trial, participants will undergo brain scans and may provide blood samples for analysis. This research could lead to better understanding and treatment options for SLE patients, making it a significant step forward in patient care.

Gender

ALL

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