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Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

NCT05789017 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-28

No results posted yet for this study

Summary

This study has been designed as a 18-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

Conditions

Interventions

DRUG

Prednisone and Mycophenolate Mofetil

Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months.

DRUG

Mycophenolate Mofetil

Patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.

DRUG

Leflunomide

Patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.

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
2024-12-31
Completion
2024-12-31

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 NCT05789017 on ClinicalTrials.gov