IgG4 related disease
Conditions
Interventions
control group:prednison combined with placebo
experimental group:prednison combined with thalidomide
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be admitted to the study: 1. According to the 2011 IgG4-RD Japanese Comprehensive Diagnostic Criteria (see below for details), Patients fulfill A+B+C are diagnosed as definite IgG4-RD, A+B: possible IgG4-RD; A+C: probable IgG4-RD: A. Clinical features: diffuse/localized swelling of one or more organs; B. Elevated serum IgG4 (>=1.35 g/L); C. Histopathology: Fibrosis and/or lymphocytic plasma cell infiltration, ratio of lgG4+/IgG+ cells >= 40 % or >= 10 IgG4+ plasma cells /HPF. 2. During the first half year of enrollment, the patient did not use the following drugs: A) Oral or intravenous administration of glucocorticoids B) Non-steroidal anti-inflammatory drugs (NSAIDs) C) Hydroxychloroquine/chloroquine drugs D) Leflunomide E) Thalidomide F) Azathioprine G) Cyclophosphamide H) Methotrexate I) Tumor necrosis factor inhibitor (TNFi) or tumor necrosis factor receptor antibody fusion protein J) Rituximab K) Other Janus kinase inhibitors 3. The patient should be at least 18 years old when enrolled; 4. Patients must agree to use a reliable contraceptive method before enrollment; 5. The subject or his/her guardian agrees to participate in the study and signs the informed consent; 6. Exclude other related diseases.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently pregnant or breastfeeding, or intend to be pregnant within half a year. 2. Patients who are in serious organ function failure(liver, heart, lung, kidney or hematogenous disease); 3. Patients who were diagnosed as malignant diseases; 4. Patients who are in active infection: HIV, HCV, HBV, TB; 5. Allergic to thalidomide; 6. A history of thrombosis; 7. Participating in other clinical trials; 8. Patients who were diagnosed with mental illness; 9. Donated or lost 400 mL or more of blood within 8 weeks before administration; 10. Under any other circumstances (for managerial or other reasons) that the investigator considers inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease remission rate;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLingli Dong
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed