Overview

Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Status:
Recruiting

Trial end date:
2024-12-01

Target enrollment:
0

Participant gender:
All

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 active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Peking Union Medical College Hospital

Treatments:

Leflunomide
Mycophenolic Acid
Prednisone

Criteria

Inclusion Criteria:

- 1. Fulfillment of the 2019 American College of Rheumatology/European League against
Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset
or relapsed patients who requires initiation or continuation of glucocorticoids
treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d.

Exclusion Criteria:

- 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were
diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection:
HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any
biologic therapy or immunosuppressive agent other than GCs.