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Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

NCT05789030 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-07

No results posted yet for this study

Summary

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

Interventions

DRUG

glucocorticoid plus iguratimod

Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months) and iguratimod (25 mg bid).

DRUG

glucocorticoid plus leflunomide

Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months ) and leflunomide (10-20 mg qd).

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Wen Zhang, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789030 on ClinicalTrials.gov