Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease (G4-FH)

IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.

The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.

These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.

The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +> 50% on tissue immunostaining.

The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.

Study Overview

• Status: Completed
• Conditions: IgG4-related Disease
• Intervention / Treatment: Biological: extra blood draw samples

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13
    • APHM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• IgG4-related disease patients or
• Sjogren syndrome patients or
• Healthy subjects

Exclusion Criteria:

• Presence of autoimmune or inflammatory associated disease
• Age less than 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IgG4-related disease; Subjects suffering from IgG4-related disease	Biological: extra blood draw samples
Active Comparator: Sjögren syndrome; Subjects suffering from Sjôgren syndrome	Biological: extra blood draw samples
Active Comparator: Healthy controls; Healthy subjects	Biological: extra blood draw samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood	36 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Urielle DESALBRES, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start: July 17, 2012
• Primary Completion (Actual): May 4, 2015
• Study Completion (Actual): May 7, 2016

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimated): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Immunoglobulin G4-Related Disease
• Other Study ID Numbers: 2011-31 (CCRRC); RC12_3608 (Registry Identifier: Assistance Publique Hôpitaux de Marseille)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No