Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation
研究概览
简要总结
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Be at least 18 years of age
- •Have been diagnosed with RA by a rheumatologist
- •Have initiated treatment with Inflectra
- •Had assessment of effectiveness in patients who have at least one follow up visit.
排除标准
- •No additional exclusion criteria
研究组 & 干预措施
outcomes after initiating Inflectra
干预措施: Inflectra (Drug)
characteristics of patients newly initiated on Inflectra
干预措施: Inflectra (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation
时间窗: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Clinical disease activity index (CDAI) was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 millimeter (mm) visual analogue scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved LDA had CDAI score less than or equal to (\<=)10. Participants with moderate or high disease activity (CDAI greater than \[\>\]10) at baseline were analyzed for this outcome measure.
次要结局
- Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation(6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation(Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Change From Baseline in CDAI at 6 Months After Inflectra Initiation(Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation(Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation(Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation(6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation(6 Months (from the retrospective data collected from the CorEvitas RA registry))
- Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation(6 Months (from the retrospective data collected from the CorEvitas RA registry))