Primary Sjogren's syndrome
Conditions
Interventions
Test group:Telitacicept 80mg subcutaneous injection once a week for 12 weeks, a total of 12 times
Sponsors
The First Affiliated Hospital of China University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily signs the informed consent form; 2. Age 18-65 years old, male or female; 3. Serum was positive when anti-Ro/SSA antibody was screened; 4. Meet the ACR/EULAR classification criteria for primary Sjogren's syndrome in 2016; 5. ESSDAI >= 6 (the dimensions of the score included: body, gland, lymph node, skin, joint, biology, blood system, kidney) and ESSPRI >= 5.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of secondary Sjogren's syndrome, such as patients with rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases; 2. Abnormal laboratory indicators of patients, including but not limited to the following indicators: White blood cell count 1.5 x ULN; Total bilirubin > 1.5 x ULN; ALT > 2 x ULN; AST > 2 x ULN; IgG and IgM levels < lower normal limit; Non-stirritant saliva flow rate and tear flow rate = 0; 3. Combined medication: (1) The dose of prednisone is unstable 2 weeks before enrollment, or the dose is greater than 15 mg per day; (2) DMARDs drugs are not allowed to be used within 12 weeks before enrollment, except methotrexate (up to 25 mg/week), hydroxychloroquine (up to 400 mg/d), azathioprine (up to 150 mg/d), but the dose should be stable for 3 months or more; (3) Targeted therapy, such as rituximab, belizumab, ababazil, anastasin, etanercept, infliximab, JAK inhibitor, was used in the first 6 months of enrollment; (4) Cyclosporine, CTX, intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before enrollment; (5) Drugs for improving dry mouth and eyes can be applied, but need to be stopped 7 days before the evaluation; 4. There is a risk of suicide, as shown by the history of attempted suicide or major suicide ideation within 6 months before the screening visit; Or, if the researcher believes that the subject is at risk of suicide attempt; 5. Pregnant and lactating women who have fertility planners or are unable to take effective contraceptive measures during the study period and within 4 months of the last administration; 6. Those who have unstable diseases other than dryness and its complications and who are at high risk of applying Telitacicept (judged by the researcher, including but not limited to: active hepatitis B, tuberculosis and other common infectious diseases, herpes zoster, tumors, heart failure, etc.); 7. Investigators assessed that the disease activity of pSS during screening was life-threatening or organ threatening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate of ESSDAI (the decrease of ESSDAI >= 3 points);Observe the difference in effectiveness of patients with different lip gland pathological grades: III-IV (focal) vs 0-II (non focal); | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of STAR;Change of ESSPRI score from baseline;the change of the investigator's overall assessment of the disease compared with the baseline;the change of the subjects' overall assessment of disease compared with baseline;The change of SF-36 (health questionnaire) from the baseline;The change of MFI-20 (multidimensional fatigue scale) compared with the baseline;Change of disease activity rate compared with the baseline period (low: ESSDAI13);Functional changes of salivary and lacrimal glands; | — |
Countries
China
Contacts
Public ContactXiaomei Li
The First Affiliated Hospital of USTC
Outcome results
None listed