NCT01474291已完成不适用
Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 608
- 主要终点
- Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion
研究概览
简要总结
This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 participants, >/= 18 years of age
- •Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy
排除标准
- •Current participation in a clinical trial in rheumatoid arthritis
结局指标
主要结局
Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion
时间窗: Day 1
The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.
次要结局
- Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12(Month 12)
- Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)(Day 1 (assessment of discontinuations within prior 2 years))
- Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period(Up to 30 months)
- Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12(Month 12)
- Percentage of Participants With CDAI Remission at Month 12(Month 12)
- Percentage of Participants With SDAI Remission at Month 12(Month 12)
- Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)(Day 1 (assessment of discontinuations within prior 2 years))
- Mean Number of Tocilizumab Infusions Over the Study Period(Up to 30 months)
- Percentage of Participants With at Least One csDMARD Intensification During the Study(Up to 30 months)
- Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide(Day 1 (assessment of discontinuations within prior 2 years))
- Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine(Day 1 (assessment of discontinuations within prior 2 years))
- Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine(Day 1 (assessment of discontinuations within prior 2 years))
- Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period(Up to 13.4 months)
- Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12(Month 12)
- Percentage of Participants With DAS28-ESR Remission at Month 12(Month 12)
- Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score(Baseline; Month 6, Month 12)
- Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.(Baseline; Month 6; Month 12)
- Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12(Month 12)
- Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12(Month 12)
- Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score(Baseline; Month 6; Month 12)
- Percentage of Participants With Adverse Events(Up to 30 months)
研究者
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