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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.
all subjects were trteated immediately with prednisone after ranomized enrollment.
Peking Univercity, People's Hospital
Beijing, Beijing Municipality, China
IgG4-RD remission rate
Evaluate treatment response by assessing changes in the IgG4 RD RI score and categorize it into three types: complete response (CR), partial response (PR), and no effect (NE, including no improvement or deterioration). IgG4 RD RI score\<3 and a decrease of ≥ 2 is considered CR; A decrease of ≥ 2 in IgG4 RD RI score but a maintenance of ≥ 3 is considered PR. If the patient's IgG4 RD RI score is initially 3 points, a decrease of 1 point after treatment is considered PR. Patients with no significant changes in tumor size and/or clinical presentation and a decrease in IgG4 RD RI score\<2 are considered NE.
Time frame: 24 week
recurrence rate
compare the recurrence rates between two groups
Time frame: 24 week
serum IgG4
compare the value of serum IgG4 between two groups
Time frame: 24 week
rate of adverse events
Compare the incidence of treatment-related adverse events and treatment-related serious adverse events
Time frame: 24 week
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