Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,532
- 试验地点
- 263
- 主要终点
- Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
研究概览
简要总结
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints 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 treatment patterns, achievement of treatment targets and maintenance of response.
Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide.
Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months.
There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
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
- •Confirmed diagnosis of moderate to severe active Rheumatoid Arthritis (RA).
- •Physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
- •Upadacitinib prescribed in accordance to the applicable approved label and local regulatory and reimbursement policies.
- •French Participants Only: Taking oral glucocorticoids ≥5 mg/day of prednisone or equivalent for at least 3 months prior to study start.
排除标准
- •Prior treatment with Upadacitinib.
结局指标
主要结局
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
时间窗: At Month 12
Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants Who Achieve Remission
时间窗: At Month 6
Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\<2.6.
次要结局
- Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification(At Month 6)
- Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission(At Month 24)
- Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission(Through Month 24)
- Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit(Through Month 24)
- Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose(Through Month 6)
- Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study(Through Month 24)
- Time to the Discontinuation of Upadacitinib(Through Month 24)
- Time to First Treatment Adjustment(Baseline (Month 0) Through Month 24)
- Percentage of Participants Achieving LDA Grouped by Therapy Strategy(Through Month 24)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy(Baseline (Month 0) Through Month 24)
- Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA(Through Month 24)
- Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose(At Month 12)
- Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit(Through Month 24)
- Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids)(Through Week 24)
- Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Monotherapy(Through Month 24)
- Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy(Baseline (Month 0) Through Month 24)
- Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Combination Therapy Strategy(Through Month 24)
- Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Combination Therapy Strategy(Through Month 24)
- Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Monotherapy(Through Month 24)
- Percentage of Participants Achieving Remission Grouped by Therapy Strategy(Through Month 24)
- Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy(Through Week 24)
- Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy(Baseline (Month 0) Through Month 24)
- Change in Morning Stiffness in Participants, Grouped by Therapy Strategy(Baseline (Month 0) Through Month 24)