Patient Outcomes: Real World Evidence in Rheumatoid Arthritis (POWER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Patterns, effectiveness, and safety of JAK inhibitors currently used in the management of RA
研究概览
简要总结
This is a prospective, real-world observational study in which patients with RA who are initiating treatment with a JAK inhibitor medication will self-report disease activity and treatment satisfaction measures using their own web-enabled device such as a smartphone. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.
详细描述
The primary objective of this study is to analyze self-reported disease activity outcomes and treatment satisfaction measures in the real world using a bring-your-own-device approach for patients with rheumatoid arthritis who are initiating a JAKi medication. An exploratory objective is to assess the feasibility of using smartphone or web-based data collection to expand upon the insights gained through the Corrona RA Registry which uses a traditional site-based approach.
POWER is a prospective, non-interventional study that will collect structured real-world data from patients with RA using a patient-centered mobile health application called ArthritisPower™. Patients planning to start treatment with a JAKi medication will self-report disease activity and treatment satisfaction through their first 3 months of therapy using their own web-enabled device such as a smartphone or computer.
Patients will be recruited from the Corrona RA Registry at the time of a routine clinical encounter.
After POWER registration, the remainder of the study is carried out using an automated data collection schedule via the web-based ArthritisPower™ application. Patients may complete assessments using a web browser or by downloading the free ArthritisPower™ application to a smartphone or tablet.
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
- •A patient MUST satisfy all of the following criteria to be eligible for enrollment into the POWER study:
- •Patient is currently participating in the Corrona RA Registry OR is eligible to participate and enrolls into the RA Registry prior to POWER study registration.
- •Patient is willing and able to complete online weekly surveys about their RA using their own computer, tablet,or smartphone and have a valid email address.
- •Patient is literate in English.
- •Patients provides consent for their data to be included in ArthritisPower™ registry in addition to providing consent to participate in the POWER study itself.
- •In conjunction with POWER registration:
- •A Corrona RA Registry Enrollment or Follow-up visit is conducted (includes both the Provider and Subject questionnaires and most recent Lab/Imaging Results if available)
- •Patient is newly prescribed* or receives their first dose of one of the following JAK-inhibitor medications: OLUMIANT® (baricitinib), RINVOQ™ (upadacitinib), or XELJANZ / XELJANZ XR® (tofacitinib)**, or any other JAK inhibitor approved during the study period.
- •The decision to treat with a new therapy must precede the decision to recruit the patient into this study. Prior use of a JAK-inhibitor medication does not exclude a patient from enrollment.
- •Patients switching to and from either formula of tofacitinib (Xeljanz 5 mg BID or the "once daily" XR 11 mg version) do not qualify for the POWER study.
排除标准
- 未提供
结局指标
主要结局
Patterns, effectiveness, and safety of JAK inhibitors currently used in the management of RA
时间窗: Through Study completion, an average of 10 years
To analyze self-reported disease activity and treatment satisfaction for patients with RA in the real world at the time of initiation with a JAK inhibitor medication.
次要结局
- Patient Reported: PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a(every 6 months for 10 years)
- Patient Reported: Treatment Satisfaction Questionnaire for Medication (9-item)(every 6 months for 10 years)
- Patient Reported: PROMIS Pain Interference(every 6 months for 10 years)
- Patient Reported: PROMIS Ability to Participate in Social Roles and Activities(every 6 months for 10 years)
- Patient Reported: PROMIS Anxiety(every 6 months for 10 years)
- Patient Reported: Duration Morning Joint Stiffness(every 6 months for 10 years)
- Patient Reported: Routine Assessment of Patient Index Data 3 (RAPID3)(every 6 months for 10 years)
- Patient Reported: Compliance Questionnaire for Rheumatology (5-item)(every 6 months for 10 years)
- Patient Reported: PROMIS Depression(every 6 months for 10 years)
- Patient Reported: PROMIS Emotional Support(every 6 months for 10 years)
- Patient Reported: PROMIS Pain Intensity(every 6 months for 10 years)
- Patient Reported: PROMIS Physical Function(every 6 months for 10 years)
- Patient Reported: PROMIS Sleep Disturbance(every 6 months for 10 years))
- Patient Reported: PROMIS Satisfaction with Participation in Discretionary Social Activities (Time Frame: every 6 months for 10 years)(every 6 months for 10 years)