Impact of UPaDacitinib Treatment on inflAmmaTion, AchiEvement of Treatment Targets and Health-related Quality of Life, Work Ability and Healthcare Resource Utilization in Moderate to Severe Rheumatoid Arthritis Patients in Hungarian Real-world Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 8
- 主要终点
- Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Remission following initiation of treatment with Upadacitinib
研究概览
简要总结
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the impact of upadacitinib treatment on achievement of remission and low disease activity in moderate to severe RA Hungarian patients in the real-world setting.
Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA. Adult participants with moderate-to-severe RA will be enrolled. Around 90 participants who are prescribed upadacitinib in routine clinical practice will be enrolled in the study in approximately 8 sites in Hungary.
Participants will receive upadacitinib as prescribed by the physician and will be followed for approximately 12 months.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.
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
- •Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
- •Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies and upadacitinib treatment was started within 1 week before the enrollment.
- •Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
排除标准
- •Participants who cannot be treated with upadacitinib as per SmPC or local prescription criteria.
- •Prior treatment course with upadacitinib or the current upadacitinib treatment was started more than 1 week prior to enrollment.
- •Participant currently participating in any interventional study.
结局指标
主要结局
Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Remission following initiation of treatment with Upadacitinib
时间窗: 6 Months
The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP \<2.6.
次要结局
- Percentage of Participants Achieving DAS28 CRP Low Disease Activity (LDA) following Initiation of Treatment with Upadacitinib(Up to 12 Months)
- Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Score(Up to 12 Months)
- Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(Up to 12 Months)
- Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score(Up to 12 Months)
- Change from Baseline in EQ-5D-5L Score(Up to 12 Months)
- Change from Baseline in Morning Stiffness Visual Analogue Scale (VAS) Score(Up to 12 months)
- HRU Questionnaire - Difference in the Number of Hospitalizations(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- HRU Questionnaire - Difference in the Number of Sick Leave Days (in employed subjects only)(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Percentage of Participants Achieving DAS28 CRP Remission following Initiation of Treatment with Upadacitinib(Up to 12 Months)
- Change from Baseline in Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA) Score(Up to 12 Months)
- HRU Questionnaire - Difference in the Number of Outpatient Visits to Each Kind of Health Care Provider(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Percentage of Participants Achieving DAS28 CRP Remission at month 6 and maintain it in all subsequent visits(Up to 12 Months)
- Percentage of Participants Achieving DAS28 CRP Low Disease Activity at month 6 and maintain it in all subsequent visits(Up to 12 Months)
- Health Resource Utilization (HRU) Questionnaire - Difference in the Number of Hospital Inpatient Days(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- HRU Questionnaire - Difference in the Number of Sick Leaves (in employed subjects only)(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Percentage of Participants remaining on Upadacitinib treatment(Up to 12 Months)