NCT03100734已完成不适用
A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 585
- 试验地点
- 1
- 主要终点
- Change from transition point in Disease Activity Score (DAS-28 score)
研究概览
简要总结
The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel.
The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.
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
- •Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice
- •Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study
- •Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period
- •Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement
- •Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy
排除标准
- •Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following:
- •Hypersensitivity to the Benepali active substance, or to any of the associated excipients
- •Sepsis, or risk of sepsis
- •Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment
- •Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator
- •Treatment with another biologic agent
- •Are currently receiving or have previously received any therapies that would preclude administration of Benepali, such as the following:
- •Immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period
- •Treatment with investigational agents within the last 6 months prior to transition point and during the period of observation.
- •Any other unspecified reasons that would, in the opinion of the Investigator, make the patient unsuitable for enrollment.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Change from transition point in Disease Activity Score (DAS-28 score)
时间窗: Approximately 3 months after the transition
Score of 28 joints examined
Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
时间窗: Approximately 3 months after the transition
Mean BASDAI score
次要结局
- Change in the DAS-28 score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Proportion of participants with low disease activity or remission over time following Transition Point(Approximately 3 and 6 months after the transition)
- Proportion of participants with worsening disease over time following Transition Point(Approximately 3 and 6 months after the transition)
- Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point(Approximately 3 and 6 months after the transition)
- Change in the General Health Score (assessed using VAS) over time following transition point(Approximately 3 and 6 months after the transition)
- Change in the BASDAI score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity(Approximately 3 and 6 months after the transition)
- Change in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate (ASDAS-ESR ) or C-Reactive Protein (CRP) score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in PAIN-VAS score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in FATIGUE -VAS score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Change in HAQ-DI score over time from the value obtained at the Transition Point(Approximately 3 and 6 months after the transition)
- Number of Participants by Demographic Category(At baseline and approximately 3 and 6 months after the transition)
- Number of Participants by Relevant Medical History(At baseline and approximately 3 and 6 months after the transition)
- Number of Participants by Disease Status(At baseline and approximately 3 and 6 months after the transition)
- Number of Participants by Relevant Medication Use(At baseline and approximately 3 and 6 months after the transition)
研究者
研究点 (1)
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