NCT04078386已完成2 期
A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.
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 Primary Sjögren's Syndrome.
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
- •Voluntarily signed informed consent ;
- •Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
- •Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies
- •ESSDAI score ≥ 5.
排除标准
- •Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases;
- •Abnormal laboratory parameters need to be excluded, including but not limited to:
- •Immunosuppressive agents were used within 4 weeks prior to randomization.;
- •The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks;
- •Use of biological agents for targeted therapy in the first 6 months of randomization;
- •Treatment of primary Sjogren's syndrome with traditional Chinese medicine and proprietary Chinese medicine within 4 weeks before randomization;
- •The use of saliva-stimulating drugs within 7 days prior to randomization;
- •Sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks;
- •Intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization;
- •Infection with herpes zoster or HIV and hepatitis C virus(HCV) antibody positive;
- •Currently suffering from active hepatitis or severe liver lesions and history;
- •Malignant tumor patients ;
- •Combined with involvement of important organs or neuropathy;
- •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 the time for the shorter).
- •Pregnant , lactating women and men or women who have birth plans during the research;
- •Investigator considers candidates not appropriating for the study
研究组 & 干预措施
RC18 240mg
Experimental
干预措施: RC18 240 mg (Biological)
RC18 160 mg
Experimental
干预措施: RC18 160 mg (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.
时间窗: week 24
ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular，peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.
次要结局
- The amount of change of ESSDAI score compared to the baseline at week 12.(week 12)
- The amount of change of European League Against Rheumatism Sjögren'sSyndrome Patient Reported Index(ESSPRI) score compared to the baseline at week 12 and week 24(week 12，24)
- Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24(week 12,24)
- Overall patient assessment of disease activity compared to baseline at week 12 and week 24(week 12,24)
- Changes in short form(SF)-36 relative to baseline at week 12 and week 24(week 12,24)
- Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24(week 12,24)
研究者
研究点 (14)
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