Sjögren's Syndrome
Conditions
Interventions
Experimental group:JAK Inhibitor Tofacitinib, oral, 5mg b.i.d, combined with Hydroxychloroquine Sulfate, oral, 0.2g-0.4g/day.
Control group:Hydroxychloroquine Sulfate, oral, 0.2g-0.4g/ day.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent voluntarily; 2. No gender limit, aged between 18-75 years; 3. Fulfill the 2016 ACR/EULAR classification criteria or the 2002 European-American joint diagnostic criteria for primary Sjögren's syndrome; 4. Take HCQ for at least 12 weeks, and the dosage is stable at 0.2g-0.4g/day; 5. ESSDAI >= 5 points.
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with secondary Sjögren’s syndrome, such as those secondary to other autoimmune diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), etc.; 2. PSS subjects with ESSDAI score = 5 times the upper limit (if the investigator considered that the elevated transaminases were related to the condition of Sjögren's syndrome itself, the subject was eligible for this trial); 5. Continuous use of immunosuppressants for more than 2 weeks within 4 weeks prior to randomization, including cyclophosphamide, leflunomide, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, iguratimod, rapamycin, etc; 6. Hydroxychloroquine was allowed to be used during the trial, and the dose remained stable for less than 4 weeks prior to randomization; 7. Biologics were used prior to randomization such as rituximab, benlysta, abatacept, anakinra, etanercept, infliximab, ticagrelor, tocilizumab, etc. (The subject was eligible for this trial after biologics discontinuation for five half-lives); 8. Chinese medicines and Chinese patent medicines for pSS (including tripterygium wilfordii polyglycosides and total glucosides of paeony root) were used within 4 weeks prior to randomization; 9. Salivary stimulating drugs were used within 7 days prior to randomization, such as anethole trithione and pilocarpine; 10. Tear substitute therapies such as sodium hyaluronate eye drops, artificial tears and carbomer eye drops can be used, but tear substitute treatments last less than 4 weeks before randomization .The medication regimen should be stopped 7 days before screening or evaluation. Subjects with lacrimal duct embolization within 5 months (such subjects can participate in this trial by flushing the lacrimal duct embolus); 11. PSS subjects who took oral glucocorticoid equivalent dose greater than 10mg prednisone acetate; pSS subjects receiving compound betamethasone intramuscular injection within 4 weeks; pSS subjects receiving intravenous glucocorticoids administration within 4 weeks; pSS subjects with a stable oral glucocorticoid dose for less than 4 weeks; 12. Subjects infected with the varicella-zoster virus within 2 weeks prior to screening; 13. Subjects previously diagnosed with AIDS; 14. Subjects currently suffering from active viral hepatitis. Subjects with positive HCV antibody. Subjects with HBsAg positivity indicated by hepatitis B five-panel test should be excluded. HBsAg negative but HBcAb positive subjects should be tested for HBV-DNA, and pSS subjects with HBV-DNA >= 500IU/ml should be excluded; 15. Subjects with present active tuberculosis; IGRAs (QFT-G) -positive subjects with prophylactic tuberculosis treatment less than 4 weeks; 16. Subjects with malignant tumor or previous tumor recurrence within 2 years prior to screening; 17. Subjects with a history of deep vein thrombosis and pulmonary embolism within 2 years prior to screening; 18. Subjects with myocardial infarction within 6 months prior to screening. 19. Subjects with invasive fungal infections (including cryptococcosis and pneumocystosis) within 6 months prior to screening; 20. Received live attenuated vaccine within 7 days prior to screening. 21. Sub
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in Sjogren's Syndrome Disease Activity Index (ESSDAI) scores at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in ESSDAI score from baseline at Week 24;The changes in ESSPRI score from baseline at Week 12 and Week 24;The ESSDAI response rates (defined as a decrease of =3 points in ESSDAI score from baseline) at Week 12 and Week 24;The ESSPRI response rates (defined as a decrease of =1 point or a 15% improvement in ESSPRI score from baseline) at Week 12 and Week 24;The statistical analysis of changes in physician global assessment (PGA) of disease activity score from baseline at Week 12 and Week 24;The statistical analysis of changes in exocrine gland function from baseline at Week 12 and Week 24;The statistical analysis of changes from baseline at week 12 and week 24 on the Quality of Life Scale (SF-36) and Multidimensional Fatigue Scale (MFI-20);The statistical analysis of changes from baseline in Patient Health Questionnaire Self-Rating Depression Scale (PHQ-9) and 7-item Generalized Anxiety Disorder Scale (GAD-7) at week 12 and week 24;The statistical analysis of changes in peripheral blood IgG and ESR from baseline at week 12 and week 24; | — |
Countries
China
Contacts
Public ContactWang Fang
Beijing Hospital
Outcome results
None listed