Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 主要终点
- Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with active RA in spite of stable dose of MTX
排除标准
- •Having received infliximab in the past
- •Having a history of serious infection which caused hospitalization within 6 months before the registration
- •Having an active tuberculosis
- •Having a complication or a history of malignancy within 5 years before the registration
研究组 & 干预措施
TA-650 3 mg/kg
干预措施: TA-650 3 mg/kg (Drug)
TA-650 6 mg/kg
干预措施: TA-650 6 mg/kg (Drug)
TA-650 10 mg/kg
干预措施: TA-650 10 mg/kg (Drug)
结局指标
主要结局
Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)
时间窗: baseline and week 54
The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient's assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient's global assessment of disease activity (VAS 0-100); c. Physician's global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.
次要结局
- Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)(54 weeks)
- Tender Joint Counts (TJC)(54 weeks)
- Swollen Joint Count (SJC)(54 weeks)
- CRP Level(54 weeks)
- Change From Baseline in DAS28(baseline and week 54)
- Change From Baseline to Week 54 in HAQ(54 weeks)
- Change in Modified Total Sharp Score (mTSS) at week54 From Baseline(baseline and week 54)
- Pharmacokinetics- Serum Concentration of Infliximab(54 weeks)
- Pharmacokinetics Positive- ATI(54 weeks)