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英夫利昔治疗类风湿关节炎的临床研究
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注册号:

Registration number:

ChiCTR-TRC-10001060 

最近更新日期:

Date of Last Refreshed on:

2015-07-03 

注册时间:

Date of Registration:

2010-10-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

英夫利昔治疗类风湿关节炎的临床研究 

Public title:

Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

英夫利昔治疗类风湿关节炎的临床研究 

Scientific title:

Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial 

研究课题代号(代码):

Study subject ID:

C008RAIIIP 

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:

包军 

研究负责人:

徐沪济 

Applicant:

Jun Bao 

Study leader:

Fuji Xu 

申请注册联系人电话:

Applicant telephone:

+86 21 81885513 

研究负责人电话:

Study leader's telephone:

+86 21 81885511 

申请注册联系人传真 :

Applicant Fax:

+86 21 63519841 

研究负责人传真:

Study leader's fax:

+86 21 63519841 

申请注册联系人电子邮件:

Applicant E-mail:

baojun@smmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

baojun@smmu.edu.cn 

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:

上海市凤阳路415号上海长征医院风湿免疫科 

研究负责人通讯地址:

上海市凤阳路415号上海长征医院风湿免疫科 

Applicant address:

415 Feng-yang Road, Shanghai, China 

Study leader's address:

415 Feng-yang Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200003 

研究负责人邮政编码:

Study leader's postcode:

200003 

申请人所在单位:

上海长征医院 

Applicant's institution:

Shanghai Changzheng Hospital 

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:

院伦审药临字第(19)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

北京大学人民医院伦理委员会 

Name of the ethic committee:

Ethic committee of People's Hospital, Beijing University 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-08-19 

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:

上海长征医院 

Primary sponsor:

People's Hospital, Beijing University; Shanghai Changzheng Hospital 

研究实施负责(组长)单位地址:

上海市凤阳路415号 

Primary sponsor's address:

415 Feng-yang Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中信国健药业有限公司

具体地址:

上海浦东新区李冰路399号

Institution
hospital:

Shanghai CP Guojian Pharmaceutical Co.,Ltd

Address:

399 Libing Road, Zhangjiang Hi-tech Park, Shanghai 201203, China

经费或物资来源:

上海中信国健药业有限公司 

Source(s) of funding:

Shanghai CP Guojian Pharmaceutical Co., Ltd 

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:

III期临床试验 

Study phase:

研究目的:

验证英夫利昔联合甲氨蝶呤治疗经一种或以上病情缓解抗风湿药治疗失败的中、重度活动性类风湿关节炎的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of infliximab in Chinese patients with active rheumatoid arthritis despite methotrexate (MTX) treatment 

药物成份或治疗方案详述:

英夫利昔 抗肿瘤坏死因子单抗注射液 

Description for medicine or protocol of treatment in detail:

infliximab anti-tumor necrosis factor monoantibody injection 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.符合美国风湿病学会1987年RA诊断标准;2.疾病处于活动期:关节肿胀≥4个,关节触痛≥6个,晨僵持续时间≥45分钟或血沉异常或CRP异常;3.甲氨蝶呤治疗至少3月,且剂量稳定;4.若口服NSAIDs或激素,NSAIDs剂量至少稳定1周,激素剂量≤10mg/天,至少稳定4周;5.HB≥80g/L,WBC≥3.5×109/L,血小板≥100×109/L,肝肾功能≤正常值上限的1.5倍;6.育龄妇女妊娠试验阴性。 

Inclusion criteria

1. Patients fulfilled the revised 1987 American Rheumatism Association criteria for the classification of RA; 2. Patients with active disease despite consecutive treatment with MTX at a stable dosage of 10-25 mg per week for at least 12 weeks before enrollment. Active RA was defines as four or more swollen joints, six or more tender joints and at least one of the following: a serum C reactive protein (CRP) level of at least 15 mg/l or an erythrocyte sedimentation rate (ESR) of at least 28 mm/hour, or morning stiffness lasting longer than 45 minutes; 3. Patients were allowed to take nonsteroidal antiinflammatory drugs or oral corticosteroids (<=10 mg/day of prednisone or equivalent) if the dose had been stable for at least 4 weeks prior to entry. 

排除标准:

1.对受试药成份过敏;2.患有全身性自身免疫性疾病;3.筛选前4周内使用除MTX之外的DMARDs、中草药、生物制剂;4.筛选时正处于急性感染或慢性感染反复发作期;5.现患活动性肝炎、结核病史;6.有恶性肿瘤、淋巴增殖性疾病史;7.孕妇 

Exclusion criteria:

1. Patient were allergic to the drug; 2. Patients receiveded intraarticular corticosteroid injections and disease modifying antirheumatic drugs (except MTX) treatment 4 weeks before the study; 3. Patiients previously received any biologic therapy; 4. Patients had significant systemic disease or autoimmune disease other than RA, acute infections, history of type B or C hepatitis, tuberculosis and malignant tumor. 

研究实施时间:

Study execute time:

From2008-12-01To 2009-12-31 

征募观察对象时间:

Recruiting time:

From2008-12-01To 2009-03-31 

干预措施:

Interventions:

组别:

试验组(受试药与MTX联合)

样本量:

0

Group:

infliximab

Sample size:

干预措施:

英夫利昔3mg/kg,第0、2、6、14周静脉注射,MTX继续原固定剂量口服(7.5~15mg)/次,每周1次,共18周

干预措施代码:

Intervention:

intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy

Intervention code:

组别:

对照组(安慰剂与MTX 对照组(安慰剂与MTX

样本量:

0

Group:

placebo

Sample size:

干预措施:

安慰剂3mg/kg,第0、2、6、14周静脉注射,MTX继续原固定剂量口服(7.5~15mg)/次,每周1次,共18周

干预措施代码:

Intervention:

intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长征医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Changhai Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疗效观察指标(ACR评分)

指标类型:

主要指标 

Outcome:

Efficacy endpoint(ACR score)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效观察指标(DAS28评分)

指标类型:

次要指标 

Outcome:

Efficacy endpoint(DAS28)

Type:

Secondary 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:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

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:

英夫利昔 是

Blinding:

Patients: blinding

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

上海长征医院

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

Shanghai Changzheng Hospital

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:

上海长征医院

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

Shanghai Changzheng Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-10-23
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