Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

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Key information

Conditions

IgG4 Related Disease Autoimmune Diseases Immune System Diseases Immunoglobulin G4-Related Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Raffaele

Milan, MI, 20132, Italy

About this study

Enquire involvement of trained immunity in the pathogenesis of IgG4RD using primary macrophages and co-cultures with patient derived fibroblasts. The investigators will first assess whether macrophages from patients are trained compared to macrophages of healthy controls and then challenge them with IgG from IgG4RD patients to evaluate the functional effects on cultivated fibroblasts.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

Adult subjects > or = 18 years of age
Subjects capable of providing informed consent
Active IgG4-RD based on the IgG4-related disease activity index
Fulfillment of the 2019 ACR/EULAR Classification Criteria for IgG4RD

Healthy Controls:

Adult subjects > or = 18 years of age
Subjects capable of providing informed consent

Exclusion criteria

Patients and healthy controls:

Subjects < 18 years of age
Pregnant women
Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
Ongoing immunosuppressive therapy

Treatment and study plan

Primary outcomes

Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures

Time frame: 7 months

Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Identification of Adaptive and Trained Immune Mechanisms Driving Tissue Fibrosis in IgG4-Related Disease

Acronym: TRIM4

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 25, 2025
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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