IgG4-related disease
Conditions
Interventions
Glucocorticoid monotherapy group:Glucocorticoid monotherapy
Glucocorticoid combined with iguratimod group:Glucocorticoid combined with iguratimod 25 mg bid
Sponsors
Beijing Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Meet the 2020 revised IgG4-RD comprehensive diagnostic criteria or the 2019 ACR/EULAR IgG4-RD classification criteria to be diagnosed as IgG4-RD; 2. Aged >= 18 years; 3. IgG4-RD RI >= 3; 4. Sign informed consent; 5. Experiencing initial IgG4-RD requiring initiation of GC therapy at the time of informed consent; or recurrent IgG4-RD requiring increased GC dose therapy at the time of informed consent (current prednisone acetate (or equivalent) dose) <= 10mg/d); 6. Willing to use high-efficiency contraceptive measures from the time of signing the informed consent to 6 months after the end of the experiment.
Exclusion criteria
Exclusion criteria: 1. Received slow-acting antirheumatic drugs or immunosuppressants other than GC within 12 weeks prior to screening (eg, azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, etc.); 2. Has received iguratimod within 12 weeks prior to screening; 3. Have serious or active infectious diseases such as hepatitis, tuberculosis, AIDS, etc.; 4. Active malignancy or a history of active malignancy in the last five years, with the following exceptions: (1) Cervical carcinoma in situ who has received curative treatment for more than 12 months before screening; (2) The basal cell or squamous cell carcinoma of the skin after curative treatment; (3) Or prostate cancer that has been treated with radical prostatectomy or curative radiation therapy for more than 3 years before screening, and has no known recurrence and is not currently receiving treatment; 5. Have an immunodeficiency disorder; 6. The presence of serious cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disease, or which, in the opinion of the investigator, may put the patient at an unacceptable risk of complications, or have a negative impact on patient safety or study results explain any other conditions causing confusion. 7. Patients with other rheumatic immune diseases (including rheumatoid arthritis, systemic lupus erythematosus, vasculitis, sarcoidosis), or IgG4-RD-like diseases such as Rosai-Dorfman's disease, Castlemen's disease; 8. Received live vaccine or live therapeutic infectious agent within 2 weeks prior to screening; 9. Patients with contraindications to iguratimod, including: (1) Female patients who are pregnant or breastfeeding, or those who plan to become pregnant in the near future; (2) Patients who are allergic to any component of the drug; (3) Patients who have induced asthma, urticaria or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs; (4) Patients with a history of gastrointestinal bleeding or perforation after application of NSAIDs; (5) Patients with active peptic ulcer/bleeding, or previous recurrence of ulcer/bleeding; 10. Participating in any clinical trial requiring the use of any drug intervention; 11. A history of alcohol or drug use that, in the opinion of the investigator, may affect patient safety or visit compliance, or interfere with safety or other study assessments; 12. Pregnant, breastfeeding, or planning to become pregnant within 6 months of the end of the experiment; 13. Estimated glomerular filtration rate 3000/mm^3; 15. Subject has the following abnormal liver function test results in the absence of hepatobiliary IgG4-RD activity: (1) Aspartate aminotransferase (AST) > 2*ULN; (2) Alanine aminotransferase (ALT) > 2*ULN; (3) Total bilirubin (TBiL) > 2*ULN; or Subjects had the following abnormal liver function test results in the presence of hepatobiliary IgG4-RD activity: (1) AST > 10*ULN; (2) ALT > 10*ULN; (3) TBiL > 5*ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate;Remission rate; | — |
Countries
China
Contacts
Public ContactYanying Liu
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed