A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 418
- 主要终点
- Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
研究概览
简要总结
This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is <500 individuals.
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
- •patients >=18 years with moderate to severe active RA for at least 6 months;
- •swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
- •inadequate response to stable dose of MTX;
- •patients of reproductive potential must be using a reliable means of contraception.
排除标准
- •rheumatic autoimmune disease other than RA;
- •patients with functional class IV RA;
- •diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
- •prior treatment failure with anti-tumor necrosis factor agent;
- •pregnant or breastfeeding women.
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
1
干预措施: methotrexate (Drug)
结局指标
主要结局
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
时间窗: Week 24
ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments: 1. Participant's global assessment of pain by Visual Analog Scale (VAS) 2. Participant's global assessment of disease activity (VAS) 3. Investigator/Physician's global assessment of disease activity (VAS) 4. Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) 5. Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)
次要结局
- Percent Change From Baseline in Pain as Assessed by the Participant at Week 24(Baseline and Week 24)
- Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24(Baseline and Week 24)
- Percentage of Participants With ACR20 and ACR70 Response at Week 24(Week 24)
- Time to Onset of ACR20, ACR50, and ACR70(Baseline and Week 24)
- Percent Change From Baseline in SJC and TJC at Week 24(Baseline and Week 24)
- Pain as Assessed by the Participant at Baseline and Week 24(Baseline and Week 24)
- Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24(Baseline and Week 24)
- Physician's Global Assessment of Disease Activity at Baseline and Week 24(Baseline and Week 24)
- Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24(Week 24)
- Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF(Baseline and Week 24)
- Change From Baseline in Hemoglobin at Week 24(Baseline and Week 24)
- SJC and TJC at Baseline and Week 24(Baseline and Week 24)
- HAQ-DI at Baseline and Week 24(Baseline and Week 24)
- Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24(Week 24)
- Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24(Week 24)
- Participant's Global Assessment of Disease Activity at Baseline and Week 24(Baseline and Week 24)
- Percent Change From Baseline in HAQ-DI at Week 24(Baseline and Week 24)
- Percentage of Participants Achieving ACR20 Response(Week 2)
- Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24(Week 24)
- Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24(Baseline and Week 24)
- Area Under The Curve (AUC) of the ACR(n)(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models(Weeks 2, 4, 8, 12, 16, 20, 24)
- AUC of DAS28(Weeks 2, 4, 8, 12, 16, 20 and 24)