Primary Sjögren’s syndrome
Conditions
Interventions
Prospective observational cohort:NA
Retrospective observational cohort:NA
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.The patient voluntarily signs the informed consent form. 2.Aged 18–65 years, male or female. 3.Patients who meet the 2016 ACR/EULAR classification criteria for primary Sjögren’s syndrome and have at least one of the cardinal symptoms:dry eyes or dry mouth. 4.Anti-SSA antibody positive; 5.ESSDAI score >=4; 6.Inadequate response or intolerance to prior therapies, and ivarmacitinib selected for treatment after shared decision-making between physician and patient, or already on ivarmacitinib therapy.
Exclusion criteria
Exclusion criteria: 1.Abnormal laboratory values, including but not limited to: • WBC 1.5 × ULN • Total bilirubin > 1.5 × ULN • ALT > 3 × ULN, AST > 3 × ULN, ALP > 2 × ULN, CK > 5 × ULN; 2.Concomitant or planned use of hydroxychloroquine, cyclophosphamide, leflunomide, methotrexate, azathioprine, mycophenolate mofetil, ciclosporin, tacrolimus, iguratimod, or any Chinese herbal medicine (e.g., tripterygium glycosides, total glucosides of paeony) with a regimen that has been stable for = 4 weeks (must be discontinued at least 7 days before screening assessments). 6.Intravenous immunoglobulin pulse therapy or plasma exchange within 4 weeks before screening. 7.Herpes-zoster infection within the past 2 weeks or positive anti-HCV or anti-HIV antibodies at screening. 8.Active hepatitis or severe hepatic disease: • HBsAg positive within 4 weeks—exclude. • HBsAg negative but HBcAb positive: test HBV-DNA; exclude if HBV-DNA positive. • HCV-RNA must be undetectable for > 4 weeks. 9.Active tuberculosis or current anti-tuberculosis therapy, or positive T-SPOT (A or B > 50) or IFN-? release assay without = 4 weeks of prophylactic anti-TB therapy; investigator will confirm activity based on clinical and imaging findings. 10.Current malignancy or history of malignancy (excluding adequately treated basal-cell carcinoma). 11.Participation in any clinical trial within 28 days or within 5 half-lives of the investigational drug (whichever is shorter) before screening. 12.Pregnant or breastfeeding women, or subjects planning conception during the study. 13.Any condition that, in the investigator’s judgment, renders the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with an ESSDAI reduction >=2 at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Week 24 outcomes: STAR response rate ;Week 24 outcomes: ESSPRI reduction from baseline ;Week 24 outcomes: SF-36 (Health Survey) improvement from baseline; | — |
Countries
China
Contacts
Public ContactWang Cheng
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed