NCT01511003已完成4 期
An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs
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
- 128
- 主要终点
- ACR20 response rate 6 months post dose
研究概览
简要总结
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria
- •Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer
- •Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL
- •Subjects with ≥ 3 swollen joints out of 66 joints assessed
- •Subjects with ≥ 6 tender joints out of 68 joints assessed
排除标准
- •Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out
- •Subjects with previous experience of tacrolimus (excluding external preparations)
- •Subjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening
- •Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening
- •Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening
- •Subjects complicated with hyperkalemia or with serum potassium level >5.5 mEq/L at screening
- •Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications
- •Subjects complicated with severe respiratory disease and infection
- •Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)
- •Subjects who were treated with other investigational product(s) within 3 months before screening
- •Other subjects who are considered ineligible for the study by the investigator
研究组 & 干预措施
Tacrolimus group
Experimental
oral
干预措施: Tacrolimus (Drug)
结局指标
主要结局
ACR20 response rate 6 months post dose
时间窗: Baseline and 6 months post dose
ACR20 is 20% improvement in ACR (American College of Rheumatology) core set
次要结局
- ACR50 response rates at month 6(Baseline and at month 6)
- ACR70 response rates at month 6(Baseline and at month 6)
- Change in bone loss rate from baseline to 6 months(Baseline and at month 6)
- Safety assessed by the incidence of adverse events, vital signs and lab-tests(For 6 months)
- Change in DAS28 from baseline to 6 months(Baseline and at month 6)
研究者
相似试验
已完成
4 期
Efficacy and Safety Study of Tacrobell to Treat Rheumatoid ArthritisRheumatoid ArthritisNCT01746680Chong Kun Dang Pharmaceutical111
已完成
4 期
A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateRheumatoid ArthritisNCT01224418Astellas Pharma Inc50
已完成
4 期
Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateRheumatoid ArthritisNCT01224041Astellas Pharma Inc78
已完成
不适用
Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexateRheumatoid ArthritisJPRN-UMIN000000512Rheumatosurgery, Osaka City University Medical School30
已完成
3 期
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)Rheumatoid ArthritisNCT02046616Hoffmann-La Roche133