IgG4-related disease (IgG4-RD)
Conditions
Interventions
Experimental group (LD-RTX group):Rituximab plus rapidly tapered glucocorticoids
Control group (GC+MMF group):Full-dose glucocorticoids plus mycophenolate mofetil
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the ACR/EULAR classification criteria for IgG4-RD 2. Active disease (IgG4-RD RI score = 3) 3. Patient age 18 to 75 years old 4. Patients who are newly diagnosed or relapsed after discontinuation of previous treatment 5. Subjects agree to participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with contraindications to or a history of allergy to rituximab or mycophenolate mofetil 2. Subjects with severe, uncontrolled infections (e.g., active tuberculosis, hepatitis B, HIV, etc.) 3. Subjects with severe myelosuppression, hepatic insufficiency, or renal insufficiency 4. Pregnant or lactating women, and those planning pregnancy without taking effective contraceptive measures 5. Have received long-term or high-dose immunosuppressive therapy within 3 months prior to enrollment 6. Subjects currently participating in other clinical trials 7. Any medical or psychiatric disorder that the investigators believe would hinder trial participants from adhering to or completing the study in accordance with the protocol. 8. Patients who refuse to comply with the requirements of this study and complete the study procedures. 9. Any other circumstances deemed unsuitable for participation in this trial by the investigators (due to administrative or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate at 6 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall remission rate at month 6;Cumulative hormone dose at month 6 and month 12;Time to disease recurrence;Proportion of patients whose serum IgG4 levels return to normal or decrease by =50% from baseline;The incidence of treatment-related adverse events and serious adverse events;Erythrocyte sedimentation rate (ESR);C-reactive protein (CRP);Immunoglobulins (IgG/A/M); | — |
Countries
China
Contacts
Public ContactShuang Ding
The First Hospital of China Medical University
Outcome results
None listed