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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06844864

Acronym

TRIM4

Enrollment

Registered

2025-02-25

Start date

2025-03-01

Completion date

2025-09-30

Last updated

2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4 Related Disease

Keywords

Trained immunity

Brief summary

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

Detailed description

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures	7 months	Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay

Countries

Italy

Outcome results