NCT06677801进行中（未招募）4 期
Changes of Immune Cell Subsets During the Treatment of Lupus with Telitacicept
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes of immune cell subsets after treatment
研究概览
简要总结
This study is a single-center cohort study. Patients with SLE who met the inclusion criteria were treated with tetanercept 160 mg once a week for a total of 24 weeks, and the clinical and laboratory indicators were collected before treatment, at the 4th week, at the 12th week, and at the 24th week, and blood samples were collected for the detection of immune cell subsets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed active SLE, who meet at least 4 of the 11 criteria for SLE revised by the United States College of Rheumatology in 1997 at the time of diagnosis;
- •Age 18~65 years old, male or female, gender ratio is not limited;
- •SLEDAI -2k score ≥ 8 points during the screening period;
- •ANA positivity as defined by a clear reference range within half a year;
- •Maintain a stable standard treatment regimen for at least 28 days prior to the date of the first dose of trial drug. Standard regimen refers to stable use of any of the following (alone or in combination): corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), other immunosuppressants or immunomodulators including azathioprine, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil), cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
- •Understand the purpose and trial steps of this trial, and voluntarily sign a written informed consent form.
排除标准
- •Renal disease: severe lupus nephritis (defined as urine protein >6g/24 hours or serum creatinine >2.5mg/dL or 221μmol/L) within 8 weeks prior to randomization, or requiring active nephritis with protocol-prohibited medications, or requiring hemodialysis or receiving prednisone ≥100mg/d or equivalent corticosteroid therapy for ≥ 14 days;
- •Neurological diseases: those with central nervous system diseases caused by SLE or non-SLE within 8 weeks prior to randomization, including but not limited to epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.;
- •Those with obvious abnormalities in laboratory examinations: a. ALT or AST≥2×ULN (upper limit of normal); b. Endogenous creatinine clearance < 30 mL/min; c. White blood cell count < 2.5×10 9/L; d. Hemoglobin <85g/L; Platelet count < 50×10 9/L;
- •Current active hepatitis or previous severe liver lesions or medical history. Hepatitis B: excludes patients who are HBsAg positive. Patients who are HBsAg negative but HBcAb positive will need to be accounted for by HBV-DNA testing: if HBV-DNA is positive, the patient is excluded from participating in the study; If HBV-DNA is negative, the patient can participate in the study. Hepatitis C: excludes patients who are positive for hepatitis C antibodies;
- •Immunodeficiency or active infection (such as herpes zoster, HIV virus infection, active tuberculosis, etc.) during the screening period;
- •Patients with other connective tissue diseases, history of malignancy, or active/recurrent peptic ulcer;
- •Pregnant women, lactating women, and males or females with birth plans during the trial;
- •Those who have received a live vaccine within 28 days prior to randomization;
- •Participation in any clinical trial within 28 days prior to randomization or within 5 times the half-life of the investigational drug enrolled in the clinical trial (whichever is longer);
- •Use of B-cell-targeted therapy agents such as rituximab, epacizumab or belimumab, etc., within 12 months prior to randomization;
- •Use of tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to randomization;
- •Those who have been treated with intravenous immunoglobulin (IVIG), prednisone ≥ 100mg/d, or equivalent corticosteroids for ≥ 14 days within 28 days prior to randomization, and those who have undergone plasmapheresis;
- •Use of interleukin-2, thalidomide, tripterygium wilfordii and tripterygium wilfordii-containing traditional Chinese medicine preparations within 28 days prior to randomization;
- •Allergic reactions: history of allergy to human-derived biological products;
- •Mentally ill persons with depression or suicidal thoughts;
- •Those who are considered inappropriate by the investigator to participate in this trial.
研究组 & 干预措施
Participant Group
Active Comparator
SLE patients treated with Telitacicept
干预措施: Telitacicept 160mg (Biological)
结局指标
主要结局
Changes of immune cell subsets after treatment
时间窗: 24 weeks
次要结局
- SLE responder index (SRI) -4(24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in KoreaHepatocellular CarcinomaNCT06620510GC Cell Corporation230
已完成
不适用
Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients.Hepatocellular CarcinomaNCT01890291GC Cell Corporation162
尚未招募
不适用
Researching trained immunity in SLE patientsSystemic lupus erythematosusNL-OMON53281Radboud Universitair Medisch Centrum100
已完成
4 期
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid ArthritisRheumatoid ArthritisNCT02557100Bristol-Myers Squibb80
已完成
4 期
Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisNCT01310166Novartis Pharmaceuticals447