Sjogren's syndrome combined with severe thrombocytopenia
Conditions
Interventions
Test group:Using Telitacicept
Sponsors
the First People's Hospital of qinzhou
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old, regardless of gender; (2) Diagnosed patients with Sjogren's syndrome, who meet at least the 2016 ACR/EULAR classification criteria, the 2002 US European consensus criteria for Sjogren's syndrome, or the 2012 SICCA classification diagnostic criteria, and have severe thrombocytopenia (platelet = 20) × 109/L) ESSDAI = 5, without significant damage to important organs such as the kidneys, nervous system, respiratory system, and cardiovascular system; (3) After treatment with rituximab, it is necessary to use tamoxifen as part of the maintenance therapy for severe thrombocytopenia in Sjogren's syndrome; (4) Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: ? Individuals known to be allergic to the investigational drug; ?Pregnant or lactating women; ? Patients who are participating in clinical studies of other drugs; ? Abnormal laboratory indicators, including but not limited to the following indicators: White blood cell count1.5 × ULN Total bilirubin>1.5 × ULN ALT>2 × ULN AST>2 × ULN IgG and IgM levels<lower normal limit Non irritating saliva flow rate, tear flow rate=0 ? Combination medication: The dosage of prednisone is unstable or exceeds 15 milligrams per day for the first 2 weeks of enrollment DMARDs drugs are not allowed to be used within 12 weeks prior to enrollment, except for methotrexate (maximum 25mg/week), hydroxychloroquine (maximum 400mg/day), and azathioprine (maximum 150mg/day), but the dosage must be stable for 3 months or more. Targeted therapy such as rituximab, belimumab, abalopram, anabaizumab, etanercept, infliximab, JAK inhibitors, etc. were used 6 months prior to enrollment;; Within 6 months prior to enrollment, cyclosporine, CTX, intravenous immunoglobulin therapy, or plasma exchange therapy; Medications for improving dry mouth and eyes can be applied, but should be discontinued 7 days before evaluation. ? Patients with combined secondary thrombocytopenia, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and other autoimmune diseases ? In addition to the above, the researchers have determined that there are other reasons that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 24 Response rate in week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with severe recurrence at 52 weeks;Changes in ESSDAI score compared to baseline;The ratio of pre - and post treatment immunological indicators (IgG, IgA, IgM, ESR, CRP) to baseline changes and recovery to normal;;The ratio of serum platelet count to baseline changes before and after treatment, and the recovery to normal.; | — |
Countries
china
Contacts
Public Contactchenanping
Qinzhou First People's Hospital
Outcome results
None listed