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NCT05880121: INLES

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

Recruiting now Last updated 30 May 2023
What this trial tests

trial testing MRI in Systemic Lupus Erythematosus in 200 participants. Currently enrolling.

Timeline
30 April 2023
Primary endpoint
30 October 2024
29 April 2026

Quick facts

Lead sponsorIRCCS San Raffaele
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date30 April 2023
Primary completion30 October 2024
Estimated completion29 April 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

15 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of MRI

Trials testing the same drug.

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

Other IRCCS San Raffaele trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing