Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis (TIARA)
2015年8月9日 更新者:Chong Kun Dang Pharmaceutical
Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis
The aims of this study are to assess the efficacy and safety of tacrolimus in patients with active rheumatoid arthritis(RA).
EULAR(European League Against Rheumatism) response at week 24 compared to baseline will be evaluated to assess the efficacy of Tacrolimus.
研究概览
详细说明
A Phase IV, Open labeled, Multi-Center Trial to Assess the Efficacy and Safety of Tacrolimus(Tacrobell®)in patients with active rheumatoid arthritis(RA).
研究类型
介入性
注册 (实际的)
111
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Seoul、大韩民国
- Kyung Hee University Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female aged ≥20years
- Signed and dated informed consent document indicating that the patient
- Women of childbearing potential must have a negative serum or urine pregnancy test at the screening visit. Except in the case of surgically sterile or amenorrhea for one year.
- Female patients must agree to use adequate contraception measures during the period of therapy which should be continued for 4 weeks.
- have RA and meet all of the following criteria; RA occurring ≥ 3months and less than 15 years and diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis; Active RA patients with MTX and among them who has insufficiency response to DMARDs as defined DAS28>3.2 in active RA patient. Insufficiency response is defined despite MTX therapy for > 12 weeks, RA activity≥ more than moderate and confirmable during 12 weeks, sequence of taking MTX >7.5mg/week for more than 6 weeks; ESR≥28mm/h or CRP≥1.0mg/dl; Tender Joint Counts must be more than 6 and Swollen Joint Counts must be more than 3
Exclusion Criteria:
- Inflammatory joint diseases, Systematic inflammatory disease
- Prosthesis and had an event of infected in it.
- Medical history of chronic infection, moderate infection or possibly to life threatening or signs and symptoms of serious infection.
- Patients have received treatment with a live vaccine from baseline within 8 weeks.
- HBsAg positive and hepatitis C virus positive patient.
- Patients have a history of malignancy. (But, carcinoma in situ of the uterine cervix or basal cell carcinoma have been treated is allowed within 5years)
- Patients have cardiovascular disease or associated disease which is not controlled.
- uncontrollable blood sugar(HbA1C ≥8%) or required insulin.
- Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.
- At screening, patients have laboratory result as defined by ; white blood cell(WBC) < 3,500/mm3, Absolute Neutrophil Count(ANC) < 1,500/mm3, Hemoglobin < 8.5g/dl, Platelet count(PLT) < 100,000/mm3, Serum creatinine >1.5*upper limit of normal or 2mg/dl, Total bilirubin > 2*upper limit of normal, aspartate aminotransferase(AST) > 2*upper limit of normal, alanine aminotransferase(ALT) > 2*upper limit of normal, alkaline phosphatase(ALP) > 2*upper limit of normal
- Patients on any other clinical trial or experimental treatment in the past 8weeks
- An impossible one who participates in clinical trial by investigator's decision
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Tacrolimus with Methotrexate
Subjects have tacrolimus per oral once daily with methotrexate for 24weeks.
Tacrolimus increased dosing regimen: 1mg for 0~4 weeks, 2mg for 4 weeks~8 weeks, 3mg for 8 weeks~24 weeks
|
Tacrolimus 1 mg for 0~week4, 2mg for week4~week8, 3mg for week8~week24 with MTX ≤20mg/week
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Change from baseline European League Against Rheumatism(EULAR) response at 24weeks
大体时间:baseline, 24weeks
|
baseline, 24weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks
大体时间:baseline, 24weeks
|
baseline, 24weeks
|
Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks
大体时间:baseline, 24weeks
|
baseline, 24weeks
|
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks
大体时间:baseline, 16weeks
|
baseline, 16weeks
|
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks
大体时间:baseline, 24eeks
|
baseline, 24eeks
|
Change from baseline C-Reactive Protein(CRP) at 16weeks
大体时间:baseline, 16weeks
|
baseline, 16weeks
|
Change from baseline C-Reactive Protein(CRP) at 24weeks
大体时间:baseline, 24weeks
|
baseline, 24weeks
|
Change from baseline European League Against Rheumatism(EULAR) response at 16weeks
大体时间:baseline, 16weeks
|
baseline, 16weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Seung -Jae Hong, phD, Dr、Kyung Hee University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2012年12月4日
首先提交符合 QC 标准的
2012年12月9日
首次发布 (估计)
2012年12月11日
研究记录更新
最后更新发布 (估计)
2015年8月11日
上次提交的符合 QC 标准的更新
2015年8月9日
最后验证
2015年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Tacrolimus with Methotrexate的临床试验
-
University of Miami Sylvester Comprehensive Cancer...The V Foundation for Cancer Research招聘中
-
The First Affiliated Hospital of Soochow UniversityFundamenta Therapeutics, Ltd.招聘中