IgG4-related disease
Conditions
Interventions
Glucocorticoid combined with Ivarmacitinib group:Glucocorticoid combined with Ivarmacitinib 4 mg qd
Glucocorticoid combined with placebo group:Glucocorticoid combined with placebo 4 mg qd
Sponsors
Beijing Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~80 years old (including 18 and 80 years old), male or female; 2. Meet the 2019 ACR/EULAR IgG4-RD classification criteria and/or the 2020 revised IgG4-RD comprehensive diagnostic criteria; 3.IgG4-RD RI>=3; 4. Initial IgG4-RD that is experiencing a primary IgG4-RD that requires initiation of GC therapy at the time of informed consent; or experiencing relapsed IgG4-RD requiring increased GC dose therapy at the time of informed consent (current dose of prednisone acetate (or equivalent)<=10 mg/d); 5. Stable dose of hormones and immunosuppressants for 4 weeks before enrollment; 6. Have the ability to understand the nature of the research and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from other rheumatic immune diseases, including but not limited to rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic sclerosis, sarcoidosis, etc.; 2. Patients with uncontrollable heart failure, arrhythmia, severe pulmonary hypertension, unstable coronary atherosclerotic heart disease and other serious cardiovascular diseases, severe gastrointestinal diseases, malignant tumors, neuropsychiatric diseases, etc., which are considered by the investigator to be unsuitable for participating in the trial; 3. Patients with a history of tumor within 5 years prior to enrollment. Patients with carcinoma in situ of the cervix or squamous epithelial tumor of the skin who have undergone radical resection within 3 years, and who have no evidence of recurrence after evaluation can be enrolled; 4. Patients with serious viral, bacterial, fungal or parasitic infections within 4 weeks prior to enrollment, which the investigator considers unsuitable to participate in the trial; 5. Female patients who are pregnant or lactating, or who have a pregnancy plan within 1 year or cannot voluntarily take effective contraceptive measures; 6. Have a history of severe liver damage or end-stage liver disease; 7. History of end-stage renal disease requiring dialysis or history of kidney transplantation; 8. History of alcohol or drug abuse within the past two years; 9. History of photosensitive dermatitis; History of peptic ulcer within 10.6 months; 11. Patients with poorly controlled psychiatric disorders; 12. Patients treated with the following medications: (1) Received treatment with any biological agents within 12 weeks prior to enrollment, including but not limited to tocilizumab, infliximab, adalimumab, etanercept, abatacept, golimumab, etc.; (2) Patients who received other B-cell depletion therapy 24 weeks prior to enrollment, including but not limited to rituximab, belimumab, etc., or intravenous infusion immunoglobulin patients; (3) Patients who have received any non-biological DMARDs or immunosuppressant therapy within 12 weeks prior to enrollment, including but not limited to cyclophosphamide, mycophenolate mofetil, methotrexate, iratimod, etc. (4) Patients who have participated in other clinical trials within 12 weeks prior to enrollment; 13. Severe abnormal blood routine test results: (1) Hemoglobin content: 3 × upper limit of normal; (2) alanine aminotransferase (ALT) > 3 × upper limit of normal; (3) Bilirubin (TBIL) > 1.5 × upper limit of normal; (4) Alkaline phosphatase (ALP) > 2.5 × upper limit of normal; 15. Subject has the following abnormal liver function test results in the presence of hepatobiliary IgG4-RD activity: (1) AST > 10 × upper limit of normal (2) ALT > 10 × upper limit of normal (3) TBIL > 5 × upper limit of normal 16. Glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate;Remission rate;Adverse effect; | — |
Countries
China
Contacts
Public ContactYanying Liu
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed