Clinical trial

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

Name
2011-31
Description
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 arms
Trial start
2012-07-17
Estimated PCD
2015-05-04
Trial end
2016-05-07
Status
Completed
Treatment
extra blood draw samples
Arms:
Healthy controls, IgG4-related disease, Sjögren syndrome
Size
75
Primary endpoint
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
36 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2023-07-28

1 organization

1 product

1 indication