NCT06844864

Brief Summary

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

February 14, 2025

Last Update Submit

April 28, 2025

Conditions

IgG4 Related Disease

Keywords

Trained immunity

Outcome Measures

Primary Outcomes (1)

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

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

    7 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with IgG4-related disease and healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • Patients and healthy controls:
  • Subjects \< 18 years of age
  • Pregnant women
  • Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
  • Ongoing immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood to isolate pbmc

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations

IT(1)