Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,067
- 主要终点
- Percentage of Participants With ≥ 1 Adverse Event
研究概览
简要总结
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.
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
- •Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
排除标准
- •Treatment with any investigational agent since the last administration of study drug in the core studies.
- •Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
- •Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
- •Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
- •Previous treatment with any cell-depleting therapies, including investigational agents.
- •Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
研究组 & 干预措施
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
干预措施: Tocilizumab (Drug)
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
干预措施: Disease-modifying anti-rheumatic drugs (Drug)
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
干预措施: Non-steroidal anti-inflammatory drugs (Drug)
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
干预措施: Oral corticosteroids (Drug)
结局指标
主要结局
Percentage of Participants With ≥ 1 Adverse Event
时间窗: Baseline to the end of the study (up to 7 years, 7 months)
次要结局
- Percentage of Participants Who Withdrew From Treatment(Baseline to the end of the study (up to 7 years, 7 months))
- Percentage of Participants With Concomitant Oral Corticosteroid Therapy(Baseline to the end of the study (up to 7 years, 7 months))
- Percentage of Participants Who Changed From Monotherapy to Combination Therapy(Baseline to Week 296)
- Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264(Baseline to Week 264)
- Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264(Baseline to Week 264)
- Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264(Baseline to Week 264)
- Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264(Baseline to Week 264)
- Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264(Baseline to Week 264)
- Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264(Baseline to Week 264)