NCT04440566

Brief Summary

This study aims at defining the role of O-GlcNAcylation is in the physiopathology of systemic lupus erythematosus (SLE). O-GlcNAcylation is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

June 17, 2020

Last Update Submit

January 18, 2024

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusautoimmunityO-GlcNAcylation

Outcome Measures

Primary Outcomes (1)

  • Quantification of O-GlcNAcylation level in the blood samples of SLE

    At baseline (Day 0)

Secondary Outcomes (3)

  • Disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

    At baseline (Day 0)

  • Disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)

    At baseline (Day 0)

  • Quantification of OGT biallelic expression in the blood samples of SLE

    At baseline (Day 0)

Study Arms (1)

Systemic lupus erythematosus (SLE)

EXPERIMENTAL
Biological: blood sample

Interventions

blood sampleBIOLOGICAL

30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Systemic lupus erythematosus (SLE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient aged over 18 years old
  • Diagnosis of systemic lupus erythematosus
  • Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

  • Pregnant or breastfeeding women,
  • Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - Service d'Immunologie et Immunogénétique

Bordeaux, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrick BLANCO, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

October 13, 2020

Primary Completion

February 14, 2022

Study Completion

February 14, 2022

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)