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COMPLETED
NCT07827469
NA

Tofacitinib in the Treatment of IgG4 Related Diseases

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1. The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.

Official title: A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2023-04-01

Completion Date

2026-06-03

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

Tofacitinib 5mg Oral Tablet

all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.

DRUG

Prednisone 5mg

all subjects were trteated immediately with prednisone after ranomized enrollment.

Locations (1)

Peking Univercity, People's Hospital

Beijing, Beijing Municipality, China