IgG4-related disease
Conditions
Interventions
Glucocorticoid combined with Rituximab group:Glucocorticoid combined with intravenous infusions of rituximab (1 g for the first dose, another 1 g infusion at Week 2, and a maintenance infusion of 1 g
Glucocorticoid combined with placebo group:Glucocorticoid combined with normal saline monoclonal antibody 1 g was infused intravenously, 1 g was infused again at the second week, and 1 g was maintain
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. For relapsed patients, stable doses of corticosteroids and immunosuppressants were given 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 uncontrolled heart failure, arrhythmia, severe pulmonary hypertension, unstable coronary atherosclerotic heart disease or other serious cardiovascular diseases, serious gastrointestinal diseases, malignant tumors, neuropsychiatric diseases, etc., who are considered by the investigator to be unsuitable for the trial; 3. Patients with a history of cancer within 5 years before enrollment. Patients with cervical carcinoma in situ or cutaneous squamous cell tumor who underwent radical resection within 3 years and had no evidence of recurrence were eligible. 4. Patients with a serious viral, bacterial, fungal, or parasitic infection within 4 weeks before enrollment that is considered by the investigator to be inappropriate for trial participation; 5. Female patients who are pregnant or lactating, or who plan to become pregnant within one year or cannot voluntarily take effective contraceptive measures; 6. A history of severe liver damage or end-stage liver disease; 7. History of end-stage renal disease requiring dialysis or renal transplantation; 8. A history of alcohol or drug abuse within the past two years; 9. History of photosensitive dermatitis; 10. History of peptic ulcer within 6 months; 11. Patients with poorly controlled mental illness; 12. Patients receiving the following medications: (1) receiving any biologic therapy within 12 weeks before enrollment, including but not limited to tocilizumab, infliximab, adalimumab, etanercept, abatacept, golimumab, etc.; (2) patients who received other B cell depletion therapy, including but not limited to rituximab, belimumab, or intravenous immunoglobulin within 24 weeks before enrollment; (3) patients who received any non-biological DMARDs or immunosuppressive therapy within 12 weeks before enrollment, including but not limited to cyclophosphamide, mycophenolate mofetil, methotrexate, iguratimod, etc. (4) patients enrolled in other clinical trials within 12 weeks before enrollment; 13. Serious abnormal blood test results: (1) hemoglobin 3 × upper limit of normal; (2) alanine aminotransferase (ALT) > 3 × upper limit of normal; (3) Total bilirubin (TBIL) > 1.5 × upper limit of normal; (4) alkaline phosphatase (ALP) > 2.5 × upper limit of normal; 15. The subjects had 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