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RECRUITING
NCT05789017
NA

Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-07-01

Completion Date

2024-12-31

Last Updated

2024-05-28

Healthy Volunteers

No

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China