NCT01746680已完成4 期
Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change from baseline European League Against Rheumatism(EULAR) response at 24weeks
研究概览
简要总结
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.
详细描述
A Phase IV, Open labeled, Multi-Center Trial to Assess the Efficacy and Safety of Tacrolimus(Tacrobell®)in patients with active rheumatoid arthritis(RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tacrolimus with Methotrexate
Experimental
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
干预措施: Tacrolimus with Methotrexate (Drug)
结局指标
主要结局
Change from baseline European League Against Rheumatism(EULAR) response at 24weeks
时间窗: baseline, 24weeks
次要结局
- Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks(baseline, 24weeks)
- Change from baseline C-Reactive Protein(CRP) at 24weeks(baseline, 24weeks)
- Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks(baseline, 24weeks)
- Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks(baseline, 16weeks)
- Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks(baseline, 24eeks)
- Change from baseline C-Reactive Protein(CRP) at 16weeks(baseline, 16weeks)
- Change from baseline European League Against Rheumatism(EULAR) response at 16weeks(baseline, 16weeks)
研究者
研究点 (1)
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