NCT02899039

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 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

Study Start

First participant enrolled

July 17, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

July 28, 2023

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

September 2, 2016

Last Update Submit

July 27, 2023

Conditions

IgG4-related Disease

Outcome Measures

Primary Outcomes (1)

  • Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood

    36 months

Study Arms (3)

IgG4-related disease

EXPERIMENTAL

Subjects suffering from IgG4-related disease

Biological: extra blood draw samples

Sjögren syndrome

ACTIVE COMPARATOR

Subjects suffering from Sjôgren syndrome

Biological: extra blood draw samples

Healthy controls

ACTIVE COMPARATOR

Healthy subjects

Biological: extra blood draw samples

Interventions

extra blood draw samplesBIOLOGICAL
Healthy controlsIgG4-related diseaseSjögren syndrome

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHM

Marseille, 13, France

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Officials

  • Urielle Desalbres

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 13, 2016

Study Start

July 17, 2012

Primary Completion

May 4, 2015

Study Completion

May 7, 2016

Last Updated

July 28, 2023

Record last verified: 2016-09

Locations

FR(1)