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小剂量重组人IL-2联合IL-6拮抗剂治疗类风湿关节炎的临床安全性和有效性研究
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注册号:

Registration number:

ChiCTR-INR-16009546 

最近更新日期:

Date of Last Refreshed on:

2016-10-21 

注册时间:

Date of Registration:

2016-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

小剂量重组人IL-2联合IL-6拮抗剂治疗类风湿关节炎的临床安全性和有效性研究 

Public title:

The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

小剂量重组人IL-2联合IL-6拮抗剂治疗类风湿关节炎的临床安全性和有效性研究 

Scientific title:

The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

张升校 

研究负责人:

李小峰 

Applicant:

Shengxiao Zhang 

Study leader:

Xiaofeng Li 

申请注册联系人电话:

Applicant telephone:

+86 18734823329 

研究负责人电话:

Study leader's telephone:

+86 13753139859 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

shengxiao_zhang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13753139859@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

山西省太原市杏花岭区五一路382号山西医科大学第二医院 

研究负责人通讯地址:

山西省太原市杏花岭区五一路382号山西医科大学第二医院 

Applicant address:

382 Wuyi Road, Taiyuan, China  

Study leader's address:

382 Wuyi Road, Taiyuan, China  

申请注册联系人邮政编码:

Applicant postcode:

030000 

研究负责人邮政编码:

Study leader's postcode:

030000 

申请人所在单位:

山西医科大学第二医院 

Applicant's institution:

the Second Hospital of Shanxi Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2016KY-007 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

山西医科大学第二医院伦理委员会 

Name of the ethic committee:

The Second Hospital of Shanxi Medical University Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-08-01 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

山西医科大学第二医院 

Primary sponsor:

the Second Hospital of Shanxi Medical University 

研究实施负责(组长)单位地址:

山西省太原市杏花岭区五一路382号 

Primary sponsor's address:

382 Wuyi Road, Taiyuan, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山西

市(区县):

太原

Country:

China

Province:

Shanxi

City:

Taiyuan

单位(医院):

山西医科大学第二医院

具体地址:

山西省太原市五一路382号

Institution
hospital:

the Second Hospital of Shanxi Medical University

Address:

382 Wuyi Road, Taiyuan, China

经费或物资来源:

自筹 

Source(s) of funding:

Self support 

研究疾病:

类风湿关节炎 

Target disease:

rheumatoid arthritis 

研究疾病代码:

M05.901 

Target disease code:

M05.901 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

研究小剂量重组人IL-2联合托珠单抗治疗对RA患者Th17/Treg细胞平衡的免疫调节作用以及对临床疗效的影响,并对两者治疗RA的安全性进行评估。 

Objectives of Study:

To evaluate the efficacy and safety of Low Dose IL-2 Conbined IL-6 Antagonist in Chinese treated patients with active rheumatoid arthritis. 

药物成份或治疗方案详述:

重组人白细胞介素-2(商品名:英路因) 重组人源化抗人白细胞介素-6受体单克隆抗体(商品名:托珠单抗) 

Description for medicine or protocol of treatment in detail:

IL-2 Tocilizumab 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

(1)年龄18~65岁,男女不限;(2)符合ACR/EULAR 2009年RA分类标准;(3)疾病处于活动期,即同时满足下面3条:①随访当日晨僵持续时间60分钟;②3个或3个以上的关节肿胀;③8个或8个以上的关节触痛;(4)血沉(ESR)28mm/小时或C反应蛋白(CRP)正常上限的1.5倍;(5)筛选时受试者必须满足下列实验室检查要求:①Hb85g/L;WBC4109/L;中性粒细胞数1.5109/L;血小板100109/L;②转氨酶正常上限的1.5倍;肌酐120mol/L(1.4mg/dl);(6)育龄妇女妊娠试验阴性并同意在试验期间及试验结束后6个月内采取有效的避孕措施;(7)受试者可以按期复诊;(8)签署知情同意书。 

Inclusion criteria

1. Male or female aged 18 and 65 years; 2. Subject fulfills the revised the 2009 ACR/EULAR criteria for the classification of RA; 3. Active RA is defined as the presence of at least 3 swollen joints and at least 8 tender joints and morning stiffness lasting longer than 60 minutes; 4. At least one of the following: a serum C reactive protein (CRP) level is at least 1.5 times of upper limit or an erythrocyte sedimentation rate (ESR) is at least 28 mm/hour; 5. Subject must meet the following requirements of laboratory tests: (1) Hb85g/LWBC4*10^9/L; Neutrophil 1.5*10^9/L; Platelet 10*10^9/L; (2) Transaminase 1.5 times the upper limit of normal Creatinine 120mol/L (1.4mg/dl); 6. Subject is negative in pregnancy test and agrees to use effective contraception during the study and for at least 6 months after stopping study treatment; 7. Subject is able to comply with scheduled visits, treatment plans and laboratory tests and other study procedures; 8. Subject or subjects legal representative has signed the informed consent form. 

排除标准:

(1)残疾、卧床、依赖轮椅、生活不能自理者;(2)患有全身性炎症疾病者,其症状及体征预期会影响对试验药物的评价,如:SLE等其它风湿性疾病;(3)筛选前5年内曾有或现患恶性肿瘤;有慢性感染病史、近2个月有严重感染的病史或近6个月内有过机会感染;当前患有活动性肝炎或有丙型肝炎病史者;HIV感染者;有如淋巴瘤等淋巴增殖性疾病病史者;有多发性硬化或者其他中枢神经脱髓鞘疾病者;曾有或现患充血性心力衰竭者;有严重的、进行性的、未控制的肝、肾、血液、胃肠道、内分泌、心、肺、神经和脑等疾病;纯蛋白衍生物(protein purified derivative, PPD)皮试阳性或(和)X线片显示肺部有感染的征象或与结核病患者有密切接触者;(4)4周内参加过其他药物观察者或近期应用过生物制剂者;(5)对受试药成份过敏。 

Exclusion criteria:

1. Patients are wholly disabled and have little or no self-care ability, such as being bedridden or confined to a wheelchair; 2. Patients have a diagnosis of any systemic inflammatory disease other than RA such as SLE, which symptoms and signs are expected to affect the evaluation of experimental drugs; 3. Patients have a history of malignancy or are suffering malignant disease within 5 years prior to study entry; Have a history of chronic or severe infection within 2 months or a history of oppotunistic infection within 6 months; Have active hepatitis or suffer from the infection of hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Have a history of lymphoproliferative disease; Have multiple sclerosis or demyelinating disease of central nervous system; Have experienced or are experiencing congestive heart failure; Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; Protein purified derivative (PPD) test is positive, or/and X - ray film showed signs of lung infection or have close contact with patients with tuberculosis (TB); 4. Patients were recruited to other clinical trial(s) involving an investigational medicinal product or are currently receiving or have received biological agents therapy within 4 weeks prior to study entry; 5. Patients are allergic to the drug compounds. 

研究实施时间:

Study execute time:

From2016-11-01To 2016-12-31 

干预措施:

Interventions:

组别:

IL-2组

样本量:

15

Group:

IL-2 group

Sample size:

干预措施:

IL-2

干预措施代码:

Intervention:

lL-2

Intervention code:

组别:

IL-2 + IL-6拮抗剂组

样本量:

15

Group:

IL-2 + IL-6 antagonist group

Sample size:

干预措施:

lL-6拮抗剂

干预措施代码:

Intervention:

Tocilizumab

Intervention code:

组别:

传统药物治疗组

样本量:

15

Group:

non IL-2 or IL-6 antagonist group

Sample size:

干预措施:

激素+免疫抑制剂

干预措施代码:

Intervention:

glucocorticoids and DMARDs

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

山西医科大学第二医院 

单位级别:

三级甲等 

Institution
hospital:

the Second Hospital of Shanxi Medical University  

Level of the institution:

Tertriary A hospital 

测量指标:

Outcomes:

指标中文名:

疗效观察指标(DAS28评分)

指标类型:

主要指标 

Outcome:

Efficacy endpoint(DAS28)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评价

指标类型:

副作用指标 

Outcome:

Safety assessment Adverse events

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血淋巴细胞亚群

指标类型:

次要指标 

Outcome:

peripheral blood lymphocyte subsets

Type:

Secondary indicator 

测量时间点:

测量方法:

流式细胞术

Measure time point of outcome:

Measure method:

Flow cytometry

指标中文名:

CD4+T亚群

指标类型:

次要指标 

Outcome:

CD4+T subgroups

Type:

Secondary indicator 

测量时间点:

测量方法:

流式细胞术

Measure time point of outcome:

Measure method:

Flow cytometry

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

计算机软件

Randomization Procedure (please state who generates the random number sequence and by what method):

Computer software

盲法:

Blinding:

None

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

山西医科大学第二医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The Second Hospital of Shanxi Medical University

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

山西医科大学第二医院

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The Second Hospital of Shanxi Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-10-21
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