Systemic Lupus Erythematosus
Conditions
Keywords
lupus erythematosus, Telitacicept, thrombocytopenia
Brief summary
The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia
Detailed description
This study is a single center, randomized, controlled trial to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus complicated with refractory thrombocytopenia.
Interventions
DRUGTelitacicept
160mg once a week for 48 weeks
DRUGconventional therapy
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
DRUGPlacebo
Used once a week in combination with standard treatment
Sponsors
Guanmin Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus; 2. Refractory thrombocytopenia (defined as receiving at least one course of methylprednisolone pulse therapy or intravenous injection of high-dose immunoglobulin or high-dose glucocorticoid combined with two or more Immunosuppressive drug failed and did not respond to any single drug); 3. SLEENA-SLEDAI score is greater than or equal to 8 points. If anti ds-DNA antibody is positive and/or low complement, SLEENA-SLEDAI score is greater than or equal to 6 points, or PLT count is\<10 \* 10 \^ 9/L or\<30 \* 10 \^ 9/L with bleeding tendency; 4. Age greater than or equal to 18 years old and less than or equal to 65 years old; 5. Have a stable SLE treatment plan, and participants should receive standard treatment for at least 30 days before randomization; 6. Positive Antinuclear antibody or anti ds DNA antibody; 7\. Sign informed documents.
Exclusion criteria
Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria: 1. Patients who are allergic to tamoxifen; 2. Patients with severe active infection, history of tuberculosis, malignant tumor, HIV, hepatitis B, hepatitis C, important organs or hematopoietic stem cells/cells/bone marrow transplantation or kidney transplantation; 3. Patients with severe active central nervous system lupus and severe active lupus nephritis 4. Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system; 5. Pregnant and lactating women; 6. Have a pregnancy preparation plan in the past year; 7. Those who have merged with other autoimmune diseases; 8. Incomplete case data and missing persons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The remission rate of SLE response index at month 12 of treatment | months 12 | Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy |
| Improvement in platelet count | months 12 | Platelet count at month of treatment，Increased platelet count indicates improvement in disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12 | months 6 and 12 | A decrease of ≥ 4 points from baseline in the SELENA-SLEDAI score indicates a good drug response effect |
| Hormone reduction | month 12 | Changes in patient hormone dose from baseline at month 12，reduced hormone dosage indicates improvement in disease |
| B lymphocyte count | month 12 | Changes in patient B lymphocyte count from baseline at month 12 |
Contacts
Primary ContactGao Guanmin
Outcome results
None listed