NCT03155243已完成不适用
Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice -HOPE
AbbVie28 个研究点 分布在 12 个国家目标入组 155 人开始时间: 2017年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 28
- 主要终点
- Proportion of participants who achieve treatment response at any of the follow-up visits
研究概览
简要总结
This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable).
- •Age >= 18 years at the time of the enrollment.
- •Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:
- •Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
- •>= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
- •>= 2+ vitreous haze [National Eye Institute (NEI)/SUN criteria]
- •Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.
- •Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.
排除标准
- •Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines.
- •Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
- •Participants currently participating in other clinical research.
- •Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.
结局指标
主要结局
Proportion of participants who achieve treatment response at any of the follow-up visits
时间窗: Up to Month 12
Definition of response: "quiescence" defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of \<=0.5+ in both eyes.
次要结局
- Percent change in Presenteeism(Up to Month 12)
- Proportion of participants with maintained response at any of follow up visits(Up to Month 12)
- Proportion of participants with maintained response separately for each follow-up visit(Up to Month 12)
- Percent Change in Total activity impairment(Up to Month 12)
- Change in emergency room admissions(From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months))
- Change in cumulative hospital admissions(From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months))
- Change in hospitalization days prior to and during Humira® treatment(From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months))
- Change from baseline in Best corrected visual acuity (BCVA)(From Month 1 to Month 12)
- Change from baseline in Central Retinal Thickness (CRT)(From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months))
- Percent change in Absenteeism(Up to Month 12)
- Percent Change in Total work productivity impairment(Up to Month 12)
- Change from baseline in intraocular pressure(From Month 1 to Month 12)
- Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score(From Month 1 to Month 12)
- Proportion of participants with flare at any of follow up visit(Up to Month 12)
- Change in outpatient visits(From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months))
- Proportion of participants with treatment response separately for each follow-up visit(Up to Month 12)
研究者
研究点 (28)
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