Suspended

A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease

What is being tested

Prednisone

Drug

Who is being recruted

Immunoglobulin G4-Related Disease

+ Autoimmune Diseases

+ Immune System Diseases

From 18 to 70 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorPeking Union Medical College Hospital

Study ContactHua Chen, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.

Official TitleA Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease

NCT01758393

Principal SponsorPeking Union Medical College Hospital

Study ContactHua Chen, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immunoglobulin G4-Related DiseaseAutoimmune DiseasesImmune System Diseases

Criteria

Inclusion Criteria: * Males and females * Age 18-70 years old with informed consent * Patients with IgG4-RD: 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2. elevated serum IgG4 (\>1.35 g/L) 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed); 4. exclusion of other diseases. Exclusion Criteria: * Previously or currently received glucocorticoid and(or) immunomodulator * Pregnancy or lactating * Concurrent severe and/or uncontrolled and/or unstable diseases * Patient with malignancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.

Group II

Experimental

Patients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, ChinaOpen Deptment of Rheumatology, Peking Union Medical College Hospital in Google Maps

SuspendedOne Study Center