An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 934
- 主要终点
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was > 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 who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.
排除标准
- •as for MA21573.
研究组 & 干预措施
tocilizumab
Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 108 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 and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience 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. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.
次要结局
- Percentage of Participants With Adverse Events Leading to Withdraw(108 Weeks)
- Time to Withdrawal Due to an Adverse Event (AE)(108 Weeks)
- Percentage of Participants With Discontinuation of Treatment Due to Any Cause(108 Weeks)
- Time to Discontinuation of Tocilizumab Treatment for Any Cause(108 Weeks)
- Percentage of Participants With Marked Lipid Abnormalities(108 Weeks)
- Percentage of Participants With Adverse Events (AEs) of Special Interest(108 Weeks)
- Percentage of Participants With ALT Elevations > 3*ULN(108 Weeks)
- Percentage of Participants With AST Elevations > 3*ULN(108 Weeks)
- Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study(108 Weeks)
- Number of Participants Categorized by Worst Value for AST (SGOT) During the Study(108 Weeks)
- Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study(108 Weeks)
- Number of Participants Categorized by Worst Value for Total Cholesterol During the Study(108 Weeks)
- Number of Participants Categorized by Worst Value for Neutrophil Count During the Study(108 Weeks)
- Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Percentage of Participants With DAS28 Low Disease Activity(Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Percentage of Participants With DAS28 Remission(Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in DAS28(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in Tender Joint Count(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in Swollen Joint Count(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in Patient Global Assessment of Disease Activity VAS(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in Physician Global Assessment of Disease Activity VAS(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Change From Baseline in C-Reactive Protein (CRP)(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Percentage of Participants With American College of Rheumatology 20 (ACR20) Response(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Percentage of Participants With American College of Rheumatology 50 (ACR50) Response(Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108)
- Percentage of Participants With American College of Rheumatology 70 (ACR70) Response(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Percentage of Participants With American College of Rheumatology 90 (ACR90) Response(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission(Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)
- Change From Baseline in FACIT-Fatigue Score(Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108)