NCT04956484已完成4 期
A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- LLDAS
研究概览
简要总结
To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).
详细描述
This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of care plus Belimumab (at a dose of 10 mg per kilogram of body weight) .
The primary endpoint is the proportion of LLDAS in week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria within three months, which is autoantibody-positive (antinuclear antibody titers ≥1:80, anti-double-stranded DNA antibodies, or both)
- •18-75 years of age
- •body weight 45-80kg
- •Disease duration of SLE ≤ 6months
- •SELENA-2K score ≥6 scores
- •Negative pregnancy test for child-bearing women at screening and baseline
- •Provide written informed consent
排除标准
- •Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
- •Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
- •Abnormal liver function (ALT or AST is 2 times higher than normal)
- •Pregnancy or breastfeeding women;
- •Have a history of malignant tumors;
- •Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)
- •Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV;
- •Previous visual obstruction, monocular dysfunction and cataract;
- •Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics;
- •Active hemorrhage or peptic ulcer;
- •With other concommitant autoimmune disease;
- •Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization.
- •Participated in other drugs clinical trials within 4 weeks.
研究组 & 干预措施
Belimumab 10 mg/kg plus standard of care
Experimental
Standard of care and Belimumab: 10 mg per kilogram of body weight，days 1 (baseline), 15, and 29 and every 28 days thereafter to week 24
干预措施: Belimumab (Biological)
Belimumab 10 mg/kg plus standard of care
Experimental
Standard of care and Belimumab: 10 mg per kilogram of body weight，days 1 (baseline), 15, and 29 and every 28 days thereafter to week 24
干预措施: Standard of care (Drug)
结局指标
主要结局
LLDAS
时间窗: week 24
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
次要结局
- LLDAS(week 12)
- Serologies(week 12, week 24)
- Dynamics of immune cell subsets(week 12, week 24)
- Remission(week 12, week 24)
- Complement levels(week 12, week 24)
- Glucocorticoid tapering(week 12, week 24)
研究者
研究点 (1)
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