Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 43
- 主要终点
- The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase
研究概览
简要总结
The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1.
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 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 695500
BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
干预措施: BI 695500 (Drug)
结局指标
主要结局
The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase
时间窗: Week 48
This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study \[1301.4\] and prior to the last date of trial medication + 180 days \[inclusive\]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.
次要结局
- The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4(Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.)
- Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4(Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.)
- The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4(Week 48)
- The Percentage of Patients Who Meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Definition of Remission [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4(Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.)