Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
概览
- 阶段
- 3 期
- 干预措施
- TA-650 3 mg/kg
- 疾病 / 适应症
- Rheumatoid Arthritis
- 发起方
- Tanabe Pharma Corporation
- 入组人数
- 327
- 主要终点
- Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)
- 状态
- 已完成
- 最后更新
- 3个月前
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.
研究者
入排标准
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
TA-650 6 mg/kg
干预措施: TA-650 6 mg/kg
TA-650 10 mg/kg
干预措施: TA-650 10 mg/kg
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)