IgG4 related diseases
Conditions
Interventions
treatment group:Telitacicept
Sponsors
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must meet the diagnostic criteria for IgG4-associated disease (2019ACR/EULAR) to be included in the study 2. Within half a year before enrollment, the patients did not use the following drugs: A) Tetazepil or other biological agents with the same or similar targets B) Tumor necrosis factor inhibitor (TNFi) or tumor necrosis factor receptor antibody fusion protein C) Rituximab (or other B cell depleting agent) 3. Patients should be at least 18 years old at the time of enrollment; 4. Patients must agree to take a reliable contraceptive measure before enrolling; 5. The subject or his/her guardian agrees to participate in the study and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently pregnant or breastfeeding, or planning to become pregnant within half a year; 2. Significant health problems or diseases, including (but not limited to) the following: poorly controlled hypertension (>=160/95 mmHg), congestive heart failure (New York Heart Association Level III or IV), poorly controlled diabetes or functioning so poorly that they are unable to take care of themselves, other autoimmune diseases; 3. The total number of white blood cells <3,000/ µL, or platelets < 100,000/ µL, neutrophils < 1,500/ µL, or hemoglobin <8.5 g/ dL (85 g/L) during screening; 4. Active systemic infection (except common upper respiratory tract infection) occurred within 2 weeks before screening; 5. Current infection, chronic or recurrent infectious disease, or evidence of latent tuberculosis infection (as determined by PPD or T-SPOT); 6. Known to be infected with HIV, hepatitis B or hepatitis C at screening time; 7. A history of lymphoproliferative disease or any known malignancy or a history of malignancy in any organ system within the last 5 years; 8. Allergic to Telitacicept; 9. Participating in other clinical trials; 10. Any medical or psychiatric condition that the Investigator considers will prevent participants from following the protocol or completing the study according to the protocol; 11. Patients refuse to comply with the requirements of this study to complete the study; 12. Any other circumstances considered by the Investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of disease remission after 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate after 24 weeks; | — |
Countries
China
Contacts
Public ContactLingli Dong
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Outcome results
None listed