An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Percentage of Participants Achieving Low Disease Activity Score
研究概览
简要总结
This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on 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 active rheumatoid arthritis (RA) of >/= 6 months duration
- •Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)
- •Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- •Autoimmune disease other than RA
- •History of or current inflammatory joint disease other than RA
- •Previous treatment with any biologic drug that is used in the treatment of RA
- •Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
- •Impaired liver, renal or hematologic function
- •Active current or history of recurrent infection
- •History of or currently active primary or secondary immunodeficiency
研究组 & 干预措施
Single Arm
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
Single Arm
干预措施: methotrexate (Drug)
结局指标
主要结局
Percentage of Participants Achieving Low Disease Activity Score
时间窗: Week 24
Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
次要结局
- Time to Achieve Low Disease Activity (DAS28 ≤3.2)(Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a Clinically Significant Improvement in DAS28 Score(Weeks 4, 8, 12, 16, 20 and 24)
- Time to Clinically Significant Improvement in DAS28(Weeks 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Time to Achieve DAS28 Remission (DAS28 <2.6)(Weeks 4, 8, 12, 16, 20 and 24)
- Percentage of Participants With DAS28 <3.2 by Visit(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response(Week 24)
- Erythrocyte Sedimentation Rate(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein Levels(Baseline, Weeks 4, 8, 12,16, 20, and 24)