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Tofacitinib in the Treatment of IgG4 Related Diseases
Sponsor: Peking University People's Hospital
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
Tofacitinib 5mg Oral Tablet
all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.
Prednisone 5mg
all subjects were trteated immediately with prednisone after ranomized enrollment.
Locations (1)
Peking Univercity, People's Hospital
Beijing, Beijing Municipality, China