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

NCT ID: NCT06844864

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-09-30

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.

Conditions

IgG4 Related Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Emanuel Della Torre

Principal Investigator, Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Raffaele

Milan, MI, Italy

Countries

Italy

Other Identifiers

2022FH5R92

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022FH5R92

Identifier Type: -

Identifier Source: org_study_id