NCT03330418终止3 期
A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Time to first relapse after randomization
研究概览
简要总结
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity.
- •EDSS 0-7.5
- •Clinical evidence of at least 2 relapses within the first two years of randomization and/ or 1 relapse within the first one year of randomization
- •Consent to use effective contraception during the study period (women of childbearing age)
- •Voluntarily signed informed consent
排除标准
- •Abnormal laboratory parameters need to be excluded, including but not limited to:
- •Currently suffering from active hepatitis or serious liver disease and medical history
- •Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization .
- •Any concomitant disease other than neuromyelitis optica（NMO）/ neuromyelitis optica Spectrum disorders（NMOSD）that required treatment with lucocorticoid.
- •pregnant , lactating women and men or women who have birth plans during the research;
- •Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.
- •Receipt of intravenous immune globulin （ IVIG） within 28 days prior to randomization.
- •Receipt of any of the following prior to randomization: Azathioprine,Cyclosporin, Methotrexate Mitoxantrone,Cyclophosphamide,Tocilizumab,Tacrolimus,Mycophenolate,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .If the patients taking leflunomide and teriflunomide,they should need to take colestyramine for elution.
- •Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking shorter time ).
- •The patients have severe psychiatric symptoms and are not compatible with clinical studies
- •Malignant tumor patients ;
- •patients experienced any of the following events within 12 weeks before screening : myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association class IV heart failure
- •Patients can't accept magnetic resonance imaging inspection during the trial.
- •Infection with herpes zoster or HIV virus at the screening;
- •The anti-hepatitis C virus （anti-HCV） of patients show positive;
- •Investigator considers candidates not appropriating for the study.
研究组 & 干预措施
Placebo Comparator
Experimental
Participants received placebo weekly administered subcutaneously for 48 times in the double-blind treatment period.Once the participants relapse,they should advance to the open phase.All participants were treated with the test drugs.
干预措施: Placebo (Biological)
RC18 160 mg
Experimental
Patients received the test group RC18 160mg weekly administered subcutaneously for 48 times.Starting with the forty-ninth dose,the trial went into the open phase . All participants were treated with the test drugs.
干预措施: RC18 160 mg (Biological)
结局指标
主要结局
Time to first relapse after randomization
时间窗: 144 weeks
次要结局
- Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144(144 weeks)
- Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144(week 4,8,12,24,36,48,60,72,96,120,144)
研究者
研究点 (1)
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