NCT01224041已完成4 期
Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study
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
- 78
- 主要终点
- ACR20 response rate compared to baseline
研究概览
简要总结
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria
- •Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator
- •ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)
- •Patients are required to have at least 3 of 66 joints assessed as swollen
- •Patients are required to have at least 6 of 68 joints assessed as painful with pressure
排除标准
- •Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
- •Previous experience of tacrolimus (ointment excluded)
- •Renal impairment or serum creatinine > 1.4 mg/dL
- •Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT > 2x upper limit normal
- •Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level >110mg/dl before the meal and >200mg/dl after the meal HbA1c > 6.4%
- •Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
- •Other investigational drug within last 30 days
- •Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
研究组 & 干预措施
Tacrolimus group
Experimental
干预措施: Tacrolimus (Drug)
结局指标
主要结局
ACR20 response rate compared to baseline
时间窗: Baseline and up to 6 months
ACR20: 20% Improvement in American College of Rheumatology Core Set
次要结局
- ACR70 response rate compared to baseline(Baseline and up to 6 months)
- ACR50 response rate compared to baseline(Baseline and up to 6 months)
- Changes from baseline in 100mm pain VAS (Visual Analogue Scale)(Baseline and up to 6 months)
- Changes from baseline in DAS 28 response rate(Baseline and up to 6 months)
- Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test(For 6 months)
研究者
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