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沙利度胺片治疗强直性脊柱炎的多中心、随机、双盲、安慰剂平行对照II期临床试验
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注册号:

Registration number:

ChiCTR-TRC-13003449 

最近更新日期:

Date of Last Refreshed on:

2016-10-08 

注册时间:

Date of Registration:

2013-06-07 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

沙利度胺片治疗强直性脊柱炎的多中心、随机、双盲、安慰剂平行对照II期临床试验 

Public title:

A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

沙利度胺片治疗强直性脊柱炎的多中心、随机、双盲、安慰剂平行对照II期临床试验 

Scientific title:

A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis 

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:

贾蔚 

研究负责人:

黄烽 

Applicant:

Jia Wei 

Study leader:

Huang Feng 

申请注册联系人电话:

Applicant telephone:

+86 021-61871700-8130 

研究负责人电话:

Study leader's telephone:

+86 010-55499013 

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:

jiaw@pharm-sh.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

fhuang1964@yahoo.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:

上海市浦东新区哈雷路898号4号楼 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

4th Building, 898 Halei Road, Shanghai, China 

Study leader's address:

28 Fuxing road, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

201203 

研究负责人邮政编码:

Study leader's postcode:

213018 

申请人所在单位:

上海医药集团股份有限公司中央研究院 

Applicant's institution:

Central Research Institute, Shanghai Pharmaceuticals Holding Co., Ltd. 

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:

003.01 

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:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

The ethic committee of The General Hospital of People's Liberation Army 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-02-04 

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:

中国人民解放军总医院 

Primary sponsor:

The General Hospital of People's Liberation Army 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Beijing, 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):

江苏省

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

常州制药厂有限公司

具体地址:

江苏省常州市劳动东路518号

Institution
hospital:

Changzhou Pharmaceutical Factory

Address:

518 East Laodong Road, Changzhou, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

强直性脊柱炎 

Target disease:

Ankylosing Spondylitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

1.评估每日口服1次沙利度胺片治疗活动期强直性脊柱炎的有效性和安全性。 2.探索每日口服1次沙利度胺片治疗活动期强直性脊柱炎的量效关系,为今后更大规模的临床试验选择合适的给药剂量提供依据。 

Objectives of Study:

1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis; 2. To explore dose-effect relationships of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 活动期AS,年龄18-65岁,门诊或住院患者,男女均可; (2) 经传统药物治疗(如使用稳定剂量的NSAIDs治疗1个月、口服糖皮质激素或DMARD药物治疗3个月)仍属活动期AS者; (3) 若为育龄期患者,女性患者或男性患者的配偶需妊娠试验阴性; (4) 具有生育能力的女性受试者在试验期间(共32周)同意采取双重医学认可的可靠避孕措施,即包括一种药物和一种非药物的避孕措施;男性受试者的配偶若具有生育能力,每次性生活时同意采用乳胶避孕套进行避孕; (5) 愿意按照方案的要求用药并按时随访检查; (6) 理解并自愿签署知情同意书。 

Inclusion criteria

(1) Active Ankylosing Spondylitis, Aged 18-65, both outpatient or inpatient, both gender; (2) AS patients after traditional therapy (Using NSAIDs in a stable dose for 1 month, using oral corticosteroids, using NSAIDs for 3 months) still in active stage; (3) Pregnancy test must be negative in the female subjects of childbearing age or wife of the male subjects; (4) Female subjects with fertility during the trial (of 32 weeks) agreed to take a double medically accepted and reliable contraceptive measures, which includes a drug and a non-drug contraceptive measures; if the spouses of male subjects have fertility, agreed to use latex condoms for contraception; (5) Willing to have the treatment according to the plan as well as do the follow-up exam on time; (6) Understand and voluntarily signed informed consent. 

排除标准:

(1) 患有或曾患有类风湿关节炎、椎间盘脱出、感染性关节炎、弥漫性特发性骨肥厚综合征、髂骨致密性骨炎、银屑病关节炎、肠病性关节炎、赖特综合征等; (2) 严重的AS,脊柱完全僵直(X线表现IV级)或病情已被证明具有较短的存活期限者; (3) 既往进行过全髋关节置换术者或适宜手术治疗者; (4) 曾使用TNF-α抑制剂等生物制品治疗者; (5) 筛选前3个月内使用过来氟米特者; (6) 严重或持续感染需要抗微生物治疗者; (7) 乙肝表面抗原或丙肝抗体检查阳性; (8) HIV抗体阳性或有获得性免疫缺陷综合症(AIDS)病史; (9) 有恶性肿瘤、淋巴增殖性疾病史; (10)有严重的糖尿病病史; (11)静息状态低血压(BP<90/50 mmHg)或高血压(BP>170/100 mmHg)和体位性低血压及具有临床意义的心电图异常; (12)过去6个月中患中风、心肌梗塞或其他严重的心血管疾病(包括心力衰竭、不稳定性心绞痛或有危及生命的心律失常及冠状动脉旁路搭桥手术); (13)外周血白细胞或中性粒细胞低于正常值下限; (14)肝功能受损,AST 或ALT水平>正常值上限的2倍; (15)肾功能受损,Cr超过正常上限2倍; (16)女性受试者或男性受试者的配偶妊娠试验阳性或处于哺乳期或准备生育或不愿意采取有效避孕; (17)有临床症状的严重药物滥用史或酗酒史或精神病患者; (18)筛选前3个月内参加过任何药物临床试验者; (19)从事危险工作者(如驾驶员、机器操纵者、高空作业者等); (20)既往有下肢深静脉血栓或肺栓塞病史的患者; (21)对受试药成份(包括赋形剂)过敏; (22)研究者认为有不宜入选的其它原因。 

Exclusion criteria:

(1) Suffering from or have suffered from rheumatoid arthritis, disc prolapse, septic arthritis, diffuse idiopathic skeletal hyperostosis syndrome, iliac dense osteitis, psoriatic arthritis, bowel disease arthritis, Reiter syndrome; (2) Severe AS, spine completely stiff (X-ray class IV) or the disease has been shown to have a shorter survival period; (3) Previously had total hip arthroplasty surgical treatment or appropriate to have the surgery; (4) Previously received anti-TNF therapy; (5) Used leflunomide within 3 months before screening; (6) Severe or persistent infection requires antimicrobial therapy; (7) Hepatitis B surface antigen or hepatitis C antibody test positive; (8) HIV positive or have acquired immunodeficiency syndrome (AIDS) history; (9) Malignancy, lymphoproliferative disease history; (10) Severe diabetes; (11) Resting hypotension (BP<90/50 mmHg) or hypertension (BP>170/100 mmHg), and orthostatic hypotension and clinically significant ECG abnormalities; (12) Over the past six months had a stroke, heart attack or other serious cardiovascular disease (including heart failure, unstable angina or life-threatening arrhythmias and coronary artery bypass graft surgery); (13) WBC or neutrophils below the lower limit of normal; (14) Liver dysfunction, AST or ALT l> 2 times the upper limit of normal; (15) Renal dysfunction, Cr>2 times the upper limit of normal; (16) Female subjects or spouses of male subjects have positive pregnancy test or be in the sickling period or intend to fertility or unwilling to take effective contraception; (17) With clinical symptoms of serious drug abuse or alcohol abuse or mental illness history; (18) Participated in any clinical trials of drugs within 3 months before screening; (19) Workers engaged in dangerous (eg drivers, machine operator, high-altitude operations, etc.); (20) A history of deep venous thrombosis or pulmonary embolism; (21) Be allergic to Test drug ingredients (including excipients); (22) Other reasons for not be enrolled. 

研究实施时间:

Study execute time:

From2013-02-05To  

征募观察对象时间:

Recruiting time:

From2013-04-25To  

干预措施:

Interventions:

组别:

沙利度胺片150mg

样本量:

80

Group:

Thalidomide 150mg

Sample size:

干预措施:

口服沙利度胺25mg/日,两周;50mg/日,两周;100mg/日,两周;150mg/日,至试验结束

干预措施代码:

Intervention:

Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd, po., to the end

Intervention code:

组别:

沙利度胺片100mg

样本量:

80

Group:

Thalidomide 100mg

Sample size:

干预措施:

口服沙利度胺25mg/日,两周;50mg/日,两周;100mg/日,至试验结束

干预措施代码:

Intervention:

Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end

Intervention code:

组别:

口服沙利度胺25mg/日,两周;50mg/日,两周;100mg/日,至试验结束

样本量:

40

Group:

Control group

Sample size:

干预措施:

口服沙利度胺模拟片

干预措施代码:

Intervention:

Placebo po.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲 

Institution
hospital:

The General Hospital of People's Liberation Army  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽省 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

蚌埠医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Bengbu Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

第二军医大学附属长海医院 

单位级别:

三甲 

Institution
hospital:

Changhai Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属中山医院 

单位级别:

三甲 

Institution
hospital:

Zhongshan Hospital Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海光华中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Guanghua Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

四川大学华西医院  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省人民医院 

单位级别:

三甲 

Institution
hospital:

Sichuan Provincial People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

苏州大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

12周时达ASAS20%受试者比例

指标类型:

主要指标 

Outcome:

Number of Subjects Achieving Assessment in Ankylos

Type:

Primary indicator 

测量时间点:

12周

测量方法:

Measure time point of outcome:

Week 12

Measure method:

指标中文名:

12周时ASDAS评分变化

指标类型:

次要指标 

Outcome:

Change of ASDAS score at week 12

Type:

Secondary indicator 

测量时间点:

12周

测量方法:

Measure time point of outcome:

Week 12

Measure method:

指标中文名:

24周时ASDAS评分变化

指标类型:

次要指标 

Outcome:

Change of ASDAS score at week 24

Type:

Secondary indicator 

测量时间点:

24周

测量方法:

Measure time point of outcome:

Week 24

Measure method:

指标中文名:

Bath强直性脊柱炎病情活动指数(BASDAI)对于基线的变化

指标类型:

次要指标 

Outcome:

Mean change from baseline in Bath Ankylosing Spond

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Bath强直性脊柱炎功能指数(BASFI)对于基线的变化

指标类型:

次要指标 

Outcome:

Mean change from baseline in Bath Ankylosing Spond

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

夜间背痛VAS评分对于基线的变化

指标类型:

次要指标 

Outcome:

Mean change from baseline in Nocturnal Pain using

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总体背痛VAS评分

指标类型:

次要指标 

Outcome:

Mean change from baseline in back pain using a VAS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

晨僵时间

指标类型:

次要指标 

Outcome:

Morning stiffness

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

晨僵时间

指标类型:

次要指标 

Outcome:

Number of Peripheral swollen joints

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周压痛关结数

指标类型:

次要指标 

Outcome:

Number of Peripheral joint tenderness

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扩胸度

指标类型:

次要指标 

Outcome:

Chest expansion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉

指标类型:

次要指标 

Outcome:

ESR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Schober试验

指标类型:

次要指标 

Outcome:

Schober test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脊柱侧弯

指标类型:

次要指标 

Outcome:

Scoliosis

Type:

Secondary indicator 

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):

采用中心分层区组随机化方法。由与本试验无关的统计人员应用SAS软件分析系统产生与样本量对等的连续流水编号,各研究中心的病例皆为2:2:1构成样本数。同时产生试验研究中心的随机号。

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

Central stratified randomization. Statisticians, independent of the study, using SAS to generate con

盲法:

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-06-07
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