IgG4-related disease
Conditions
Interventions
Experimental group:Telitacicept combined with standard treatment
Sponsors
The First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old. 2. Meets the 2019 ACR/EULAR IgG4-RD classification criteria. 3. Relapsing active disease: Previously achieved remission through treatment (glucocorticoids and/or immunosuppressants/biologics), and currently in a state of disease recurrence. Recurrence is defined as the appearance of new or recurrent symptoms, signs, and/or active progression of the original affected organ lesions (confirmed by imaging). Judged by the investigator based on clinical manifestations, laboratory and imaging results. 4. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Merge patients with other rheumatic diseases and allergic disorders. 2. Have an allergy to tofacitinib or any of its excipients. 3. Received high-dose glucocorticoid (equivalent dose of prednisone > 30mg/day) pulse therapy or intravenous immunoglobulin (IVIG) within 4 weeks before enrollment. 4. Received rituximab (RTX) or other B-cell depletion therapy within 12 weeks before enrollment. 5. Used other biologics or investigational drugs within 8 weeks before enrollment. 6. Have severe, uncontrolled infections (such as active tuberculosis, HIV, HBV/HCV active replication, deep fungal infections, etc.), or infections requiring intravenous antibiotics/antiviral treatment. 7. Have active malignant tumors or a history of malignant tumors within the past 5 years. 8. Have severe and uncontrolled cardiovascular, respiratory, liver, kidney or hematological diseases. 9. Have a severe immunodeficiency state (such as primary immunodeficiency, severe hypogammaglobulinemia, etc.). 10. Have active peptic ulcers or severe gastrointestinal diseases that may affect drug absorption. 11. Pregnant or lactating women. 12. Have a history of mental illness or drug abuse that may interfere with study assessment or compliance. 13. Any other situation that the investigator considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serological indicators;Recurrence rate;IgG4-RD Response Index Score;Usage of glucocorticoids; | — |
Countries
China
Contacts
Public ContactKui Zhang
The First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Outcome results
None listed