Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease (TRIM4)

April 28, 2025 updated by: Emanuel Della Torre, IRCCS San Raffaele

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

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132
        • Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with IgG4-related disease and healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022FH5R92 (Other Grant/Funding Number: Ministero dell'Università e della Ricerca)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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