Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
研究概览
简要总结
This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Confirmed moderate or severe rheumatoid arthritis
- •Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)
排除标准
- •Presence of infectious diseases [tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C]
- •Inadequate hematologic, renal or liver function
- •Peptic ulcer disease (in acute phase)
- •Pregnant and lactating women
研究组 & 干预措施
tocilizumab [RoActemra/Actemra]
Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: 12 weeks
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Change From Baseline in Disease Activity 28 (DAS28) Score
时间窗: Baseline, Week 12
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved
时间窗: Baseline, Week 12
American College of Rheumatology (ACR) ACR20, ACR50 or ACR70 response is defined as a ≥ 20% or 50% or 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
次要结局
未报告次要终点