UPwArds - Post Marketing Observational Study to Evaluate the Impact of CRP-Level on the Real World Effectiveness of UPadacitinib When Used in MonotherApy or in Combination With MTX in Patients With RheumatoiD ArthritiS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 52
- 主要终点
- Percentage of Participants Achieving Remission
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. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (MTX). This study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of RA.
CRP is an indicator of inflammation and often used for disease activity monitoring during RA treatment. Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. This study has two groups - upadacitinib monotherapy and combination. Adult participants with moderate to severe RA will be enrolled. Around 500 participants will be enrolled in the study in multiple sites within Germany.
Participants will receive upadacitinib alone or in combination with MTX per their physicians' usual prescription. Individual data will be collected for 12 months.
No additional study-related tests will be conducted during the routine physician visits. 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.
- •Swollen Joint Count (SJC) >= 3 of 28 joints of the Disease Activity Score (DAS)
- •Measurement of C-Reactive Protein (CRP)-level at Baseline (BL) or <= 4 weeks prior to BL at a timepoint when the Prednisolone equivalent dose of Glucocorticoid treatment was <= 10 mg/day for at least 7 days.
- •Upadacitinib treatment is indicated as per local Summary of Product characteristics (SmPC).
- •Decision on the treatment with Upadacitinib 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 Upadacitinib according to the local Upadacitinib SmPC.
- •Prior treatment with Upadacitinib.
- •Treatment with Sarilumab or Tocilizumab within the last 8 weeks before the CRP level for inclusion was measured.
- •Participants currently participating in interventional research.
- •Participants who are unwilling or unable to complete the patient reported questionnaires.
结局指标
主要结局
Percentage of Participants Achieving Remission
时间窗: 6 Months
Remission is defined as clinical disease activity index (CDAI) \<=2.8
次要结局
- Mean Change From Baseline in DAS28-ESR(Up to 12 Months)
- Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %)(Up to 12 Months)
- Mean Change From Baseline in Fatigue(Up to 12 Months)
- Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID)(Up to 12 Months)
- Percentage of Participants Achieving RAID <= 3(Up to 12 Months)
- Change From Baseline in Patient Health Questionnaire (PHQ-9)(Up to 12 Months)
- Mean Change From Baseline in DAS28-CRP(Up to 12 Months)
- Percentage of Participants Achieving Pain Reduction (Improvement by 70 %)(Up to 12 Months)
- Change From Baseline in Morning Stiffness Severity(Up to 12 Months)
- Mean Change From Baseline in CDAI(Up to 12 Months)
- Percentage of Participants Achieving Pain Reduction (Improvement by 50 %)(Up to 12 Months)
- Percentage of Participants Achieving Remission(Up to 12 Months)
- Mean Change From Baseline in Pain(Up to 12 Months)
- Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %)(Up to 12 Months)
- Percentage of Participants With Low Disease Activity (LDA) or Remission Without Actual Concomitant MTX(Up to 12 Months)
- Percentage of Participants Achieving Low Disease Activity (LDA)(Up to 12 Months)
- Mean Change From Baseline in SDAI(Up to 12 Months)
- Percentage of Participants Achieving Pain Reduction (Improvement by 30 %)(Up to 12 Months)
- Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %)(Up to 12 Months)
- Percentage of Participants Achieving RAID > 3 and <=4(Up to 12 Months)
- Percentage of Participants Achieving RAID > 4 and <=6(Up to 12 Months)
- Percentage of Participants Achieving RAID > 6(Up to 12 Months)
- Change From Baseline in Morning Stiffness Duration(Up to 12 Months)
- Percentage of Participants With LDA or Remission With Actual Concomitant MTX(Up to 12 Months)
- Change From Baseline in Functionality (FFbH)(Up to 12 Months)
- Percentage of Participants With Minimal Clinically Important Difference (MCID) in PHQ-9(Up to 12 Months)