Sjögren's Syndrome
Conditions
Interventions
Experimental Group:Experimental Group: Telitacicept 160mg subcutaneously injected once weekly for 12 consecutive weeks, followed by drug withdrawal and continued follow-up until Week 24.
Control Group:Control Group: Hydroxychloroquine 200mg orally administered twice daily for 24 consecutive weeks.
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (as of the screening date), regardless of gender; 2. Patients diagnosed with primary Sjögren's syndrome who meet the 2002 revised International Classification (Diagnostic) Criteria for Sjögren's Syndrome or the 2016 ACR/EULAR Classification Criteria for Primary Sjögren's Syndrome; 3. ESSDAI score >= 5; 4. Complicated with hypergammaglobulinemia (IgG > upper limit of normal); 5. No use of hydroxychloroquine, immunosuppressants (such as MTX, LEF, GC > 10mg/d, etc.) within 4 weeks before enrollment, or discontinuation of such drugs for more than 4 weeks to ensure consistent baseline treatment; 6. Female subjects with a negative pregnancy test; agreement to use effective contraceptive measures during the trial; 7. No severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease, etc.; 8. Understand the purpose and procedures of the trial, and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with or complicated by other diffuse connective tissue diseases; 2. Pregnant women, lactating women, and men or women planning to conceive in the near future; 3. Positive HIV antibody, positive syphilis serological antibody; known HIV infection, known acquired immunodeficiency; known immunocompromised state; 4. Patients with malignant tumors; 5. Patients with active infections who require treatment with injectable anti-infective drugs within 28 days before the first administration of the study drug, or oral anti-infective drugs within 14 days before the first administration of the study drug; 6. Patients with severe arrhythmia detected by electrocardiogram; 7. Patients allergic to the study drug; 8. Patients with mental illness, a history of alcoholism, or abuse of drugs or other substances; 9. Other conditions deemed by the investigator to make the patient ineligible for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunoglobulin;EULAR Sj?gren's Syndrome Disease Activity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| EULAR Sj?gren's Syndrome Patient Reported Index;Ocular Dryness Visual Analogue Scale;Xerostomia Visual Analogue Scale;Global Visual Analog Scale;Schirmer test;Complement C3;Complement C4;Erythrocyte Sedimentation Rate;C-Reactive Protein;Rheumatoid Factor; | — |
Countries
China
Contacts
Public ContactWu Rui
The First Affiliated Hospital of Nanchang University,
Outcome results
None listed