IgG4-RD
Conditions
Interventions
Titacercept group:GCs+titacercept
Control group:GCs
Sponsors
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients should be at least 18 years old at the time of enrollment; 2. Obtain written informed consent from the subject and any authorizations required by the institution (e.g., data privacy) prior to conducting any procedures related to the study protocol, including screening assessments. 3. Clinical diagnosis was IgG4-RD. 4. According to the Qualification Committee, it meets the 2019 ACR/EULAR classification standard. 5. Was experiencing (or had recently experienced) a recurrence of IgG4-RD that required the initiation or continuation of GC therapy at the time of informed consent. 6. At any time during the course of IgG4-RD, IgG4-RD involves at least two organs/sites, supported by documentary evidence. One organ must meet the requirements of the ACR/EULAR classification criteria (Inclusion Criterion 4); The second organ is defined by the researcher. 7. Willing and able to follow the study protocol, complete the study evaluation and complete the study period. 8. Unsterilized male subjects who have active sex with a potentially fertile female partner must use a condom containing spermicide (if spermicide is available) from day 1 to the end of the study and must agree to continue using such contraception for at least 6 months after the last dose. Women with reproductive potential who are sexually active must use a highly effective contraceptive method from the time they sign an informed consent and must agree to continue using such contraceptive method until the end of the study follow-up period and until at least 180 days after the last dosing; Discontinuation of contraception after this time should be discussed with the responsible physician. Periodic abstinence, safe period contraception and external ejaculation are not acceptable methods of contraception. Female partners of male study participants (with reproductive potential) will be advised that they should use a highly effective method of contraception in addition to the barrier method. Women with reproductive potential were defined as those who had not been surgically sterilized (surgical sterilization included bilateral tubal ligation, bilateral oophotomies, or hysterectomies) or were non-postmenopausal (defined as 12 months of menopause without other medical reasons, and clinical laboratory tests determined that FSH was in the postmenopausal range).
Exclusion criteria
Exclusion criteria: 1.The presence of serious cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disease, or any other condition that the investigator believes may place the patient at an unacceptable risk of complications, interfere with the evaluation of IP, or confounding the interpretation of patient safety or study results. 2. A history of solid organ or cell transplantation. 3. Known immunodeficiency diseases. 4. Presence of active malignant tumor or history of active malignant tumor in the last 10 years, except in the following cases: - Cancer in situ of the cervix that has undergone curative treatment for more than 12 months prior to screening, - Basal cell or squamous cell carcinoma of the skin after curative treatment, or - Prostate cancer that has been treated with radical prostatectomy or curative radiation for more than 3 years prior to screening, has no known recurrence, and is not currently receiving treatment. 5. Received any B-cell depletion biologic therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening. 6. Subjects who have received non-expendable B-cell targeted therapy (e.g., belimumab), abatacept, or other biological immunomodulator in the 6 months prior to screening. 7. Received abiotic DMARD or immunosuppressants other than GC (e.g. Azathioprine, mycophenolate, methotrexate, etc.) in the 4 weeks prior to screening. 8. Received any investigational drug within 12 weeks prior to screening or within 5 half-lives of the drug. 9. According to the investigators, participants were unable to reduce and discontinue GC therapy until 8 weeks after randomization (except those taking prednisone or its equivalent =2.5 mg/ day for adrenal insufficiency or intolerance to tapering). 10. Received live vaccine or live therapeutic sexually transmitted pathogens within 2 weeks prior to screening. 11. Pregnancy, breastfeeding, or planning to become pregnant within 6 months after the last IP administration. 12. Have tested positive for hepatitis B or HIV infection, or have previously been treated accordingly. A positive hepatitis B test result means the detection of (1) Hepatitis B surface antigen (HBsAg); Or (2) Hepatitis B core antibodies (anti-HBC). 13. A history of uncured hepatitis C infection or a positive test result for antibodies to hepatitis C virus (HCV), unless the patient is considered cured after antiviral therapy and the HCV viral load is below the detection limit at least 24 weeks after completing treatment at a research center or central laboratory. 14. There is evidence of active tuberculosis (TB) or a higher risk of TB. 15. A history of more than 1 episode of shingles (of any grade) and/or any other established or probable opportunistic infection in the 12 months prior to screening. 16. A known history of allergy or reaction to any component of a formulation of titacept or to any gammaglobulin therapy by any person. 17. Allergy or intolerance to the treatment prescribed in the study protocol, including medications used to prevent infusion reactions (antipyretics such as paracetamol/acetaminophen or equivalent, diphenhydramine or equivalent, and methylprednisolone or equivalent). 18. The estimated glomerular filtration rate calculated according to the MDRD formula was <30mL/min/1.73m². 19. Blood tests performed at screening meet any of the following criteria: - Hemoglobin < 7.5 g/dL - Neutrophils < 1200/mm3 - Platelets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, serious adverse events, and adverse events of particular concern;Annual recurrence rate;The proportion of complete remission at week 52;The time to the start of the investigator's first treatment for new or aggravated disease activity (whether or not determined to be recurrent by a clinical professional) during the observation period.;Glucocorticoid dosage; | — |
Countries
China
Contacts
Public ContactDong Lingli
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Outcome results
None listed