Immunoglobulin G4-Related Disease, Janus Kinase Inhibitors
Conditions
Keywords
IgG4-related Disease, Tofacitinib,efficacy, safety
Brief 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.
Interventions
DRUGTofacitinib 5mg Oral Tablet
all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.
DRUGPrednisone 5mg
all subjects were trteated immediately with prednisone after ranomized enrollment.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18 ≤ Age ≤ 70 years old; 2. Complies with the 2019 ACR/EULAR IgG4 RD classification criteria 3. Patients with initial or recurrent active IgG4 RD (IgG4 RD RI ≥ 3 points). 4. Voluntary signing of informed consent: Patients must be given a written consent form when participating in the trial, and it is hoped that patients can comply with the requirements of the study follow-up plan and other protocols; 5. Female participants of childbearing age agreed to use effective contraceptive measures during the study period.
Exclusion criteria
1. Participants in other trials or those who have participated in clinical trials of other drugs within 2 months; 2. Individuals who have received live vaccine immunization within 2 weeks prior to enrollment, or who require live vaccine immunization during the trial period; 3. Merge other autoimmune diseases 4. Active infected individuals need to be excluded. Latent tuberculosis requires prevention with isoniazid 0.3g/d one month in advance; People with hepatitis B HBsAg+and HBV-DNA negative need to take anti hepatitis B virus drugs one month in advance. 5. Pregnant and lactating women, or women of childbearing age who have fertility requirements during the study period and within 6 months after the last dose of medication; 6. Patients with a history of thromboembolism, or severe diseases such as coronary heart disease and other important organs such as the heart, brain, liver, lung, kidney, and hematopoietic system, malignant tumors, and psychiatric disorders; 7. Other researchers believe that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgG4-RD remission rate | 24 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence rate | 24 week | compare the recurrence rates between two groups |
| serum IgG4 | 24 week | compare the value of serum IgG4 between two groups |
| rate of adverse events | 24 week | Compare the incidence of treatment-related adverse events and treatment-related serious adverse events |
Countries
China
Outcome results
None listed