3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 29, 2022

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
BIOLOGICAL

Blood sample

"\- Total volume of blood (on each sampling occasion): 54,5mL.~* Whole blood will be collected in EDTA, 1 tube of 10 mL for DNA (genotyping, methylation arrays; at baseline for genotyping and at EOS visit for methylation arrays). From this, an aliquot of 0.5 mL for baseline cell numbers (cell proportions, CyTOF/flow cytometry) at all time points; capture of leukocytes for blood single cell RNA seq. at all time points and 5 mL for cell stimulations for cell metabolome (C13 to be added), and 1 tube of 10 mL for cell stimulations (CyTOF) at baseline.Tempus tube: 1 tube of 3 mL for RNA, 1 tube of 3mL for whole blood RNA seq.; to be taken at all time points. Plasma will be obtained and aliquoted from these tubes; to be obtained at all time points.~* Serum: 2 tubes of 10 mL without anticoagulant for measurements of anti-drug antibodies, hydroxychloroquine levels, cytokines and analytes, proteome, and autoantibodies; to be taken at all time points."

BIOLOGICAL

Urine sample

\- Urine: 100 mL which will be centrifuged. The pellet will be frozen, and the urine supernatant will be aliquoted;

BIOLOGICAL

Saliva sample

\- Saliva: will be collect in special container for saliva microbiome and methylation;

BIOLOGICAL

Stood sample

\- Stool: One sample for microbiome to be sent to the biobank, frozen at -80 °C

PROCEDURE

Tissue sample

"\- Tissue samples for organ-specific manifestations:~* Kidney tissue in lupus nephritis: one small fragment of the fresh kidney biopsy will be stored in a 10% dimethyl sulfoxide (DMSO) solution (slow freezing to -80 °C) until shipment.~* Skin tissue (at selected centers) from inflamed lesion and non-inflamed skin from the gluteal region will be obtained through punch biopsy and stored in a 10% dimethyl sulfoxide (DMSO) solution (slow freezing to -80 °C) until shipment.~* Synovial tissue (at selected centers) will be obtained through ultrasound-directed arthroscopy and stored in a 10% dimethyl sulfoxide (DMSO) solution (slow freezing to -80 °C) until shipment.~* Aspirate from swollen lymph nodes (at selected centers) will be obtained and stored in a 10% dimethyl sulfoxide (DMSO) solution (slow freezing to -80 °C) until shipment."

Trial Locations (1)

29609

01- CHU Brest, Brest

All Listed Sponsors
lead

University Hospital, Brest

OTHER