NCT02287610已完成不适用
A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 75
- 主要终点
- Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit
研究概览
简要总结
The overall objective of the study is to assess the effectiveness of switching from immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in patients with moderately to severely active Rheumatoid Arthritis (RA), managed according to standard of care in clinical practice settings.
详细描述
Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone and followed for approximately 12 weeks.
Study with completed results acquired from Horizon in 2024.
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
- •Age ≥ 18 and in general good health (Investigator discretion) with a recent stable medical history other than related to RA disease activity
- •RA diagnosis is ≥ 6 months according to ACR and/or EULAR classification criteria for diagnosis of active RA
- •Morning stiffness duration of at least 45 minutes at study entry
- •RA disease activity as defined by DAS28 of ≥ 3.2 at study entry
- •Currently receiving conventional immediate-release prednisone ≥ 2.5 milligram (mg) every morning and previously agreed to switch to RAYOS
- •Willing and able to sign an Informed Consent Form (ICF)
排除标准
- •Patient is unwilling to participate in the non-interventional study
结局指标
主要结局
Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit
时间窗: Baseline to Last Follow up visit (up to 18.7 weeks)
Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to "Not Severe at All" and 100 to "Extremely Severe". This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up.
次要结局
- Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow-up visit (up to 18.7 weeks))
- Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- ACR-N From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Assessment of Unsolicited Adverse Events(Baseline to Last Follow up visit (up to 18.7 weeks))
- Assessment of Unsolicited Serious Adverse Events(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) "How do You Feel Today (Compared to One Week Ago)" Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
- Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)(Baseline to Last Follow up visit (up to 18.7 weeks))
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