NCT01254331已完成3 期
Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death
研究概览
简要总结
This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >/=18 years of age
- •Moderate to severe rheumatoid arthritis defined as DAS 28>3.2
- •Body weight </=150 kg
- •Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
- •Inadequate clinical response to a stable dose of a non-biologic DMARD
排除标准
- •Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- •Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
- •Functional class IV as defined by the ACR classification
- •History or current inflammatory joint disease other than RA
- •Previous treatment with any cell depleting therapy
- •Previous treatment with methotrexate
- •Previous treatment with tocilizumab
- •Previous treatment with any biologic drug that is used in the treatment of RA
研究组 & 干预措施
Single arm
Experimental
干预措施: tocilizumab [RoActemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death
时间窗: Baseline, every 4 weeks through Week 52
次要结局
- Percentage of Participants Achieving LDA Assessed Using DAS28(Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Percentage of Participants Achieving Remission Assessed Using DAS28(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Number of Participants Who Discontinued Tocilizumab(Week 52)
- Mean C-Reactive Protein (CRP) Levels(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Percentage of Participants Experiencing Fatigue(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)(Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Assessment of Pain by the Participant Using Visual Analog Scale (VAS)(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- SJC and TJC(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Assessment of Global Disease by the Participant Using VAS(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)(Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Time To Achieve ACR20/ACR50/ACR70(Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
- Mean Erythrocyte Sedimentation Rate (ESR) Levels(Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52)
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