NCT03841318

Brief Summary

The study aims at defining the role of immune cells derived from the intestine in the pathogenesis of Sjogren's disease. This research might open new therapeutic approaches for the treatment of autoimmune diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

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

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

May 20, 2026

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

February 13, 2019

Last Update Submit

May 19, 2026

Conditions

Sjogren's Syndrome

Keywords

lymphoid cellsgut-derived lymphocytes

Outcome Measures

Primary Outcomes (1)

  • Quantification of the immune cells infiltrated in the minor salivary glands of Sjogren's patients.

    At baseline (Day 0)

Secondary Outcomes (1)

  • Quantification of disease activity scores for Sjogren's patients evalued by EULAR Sjögren Syndrome Disease Activity Index

    At baseline (Day 0)

Study Arms (1)

Sjogren's Syndrome

EXPERIMENTAL
Biological: blood sampleBiological: biopsy of the labial salivary gland

Interventions

blood sampleBIOLOGICAL

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

Sjogren's Syndrome
biopsy of the labial salivary glandBIOLOGICAL

Part of the biopsy of the labial salivary gland

Sjogren's Syndrome

Eligibility Criteria

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

You may qualify if:

  • Suspicion of Sjogren's syndrome based on 2016 American College of Rheumatology (ACR) criteria;
  • Age ≥ 18 years
  • Being affiliated to health insurance
  • Willing to participate

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 de médecine interne

Bordeaux, France

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre DUFFAU, 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

February 13, 2019

First Posted

February 15, 2019

Study Start

August 3, 2020

Primary Completion

September 27, 2022

Study Completion

September 27, 2022

Last Updated

May 20, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)