Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05789030

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Led by Peking Union Medical College Hospital · Updated on 2026-04-07

60

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with superficial organ involvement: prednisone plus iguratimod and prednisone plus leflunomide.

CONDITIONS

Official Title

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria
  • Newly-onset or relapsed IgG4-RD patients requiring initiation or continuation of glucocorticoid treatment
  • Patients starting glucocorticoid treatment at less than 10 mg per day
Not Eligible

You will not qualify if you...

  • Diagnosis of other autoimmune diseases
  • Diagnosis of malignant diseases
  • Pregnant or breastfeeding women
  • Active infections such as HIV, HCV, HBV, or tuberculosis
  • Severe irreversible organ damage
  • Use of biologic therapy or immunosuppressive agents other than glucocorticoids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

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Research Team

Y

Yunyun Fei, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement | DecenTrialz