A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Rheumatoid Arthritis: A Comparison of the Effectiveness of Biologic Monotreatment and Biologic and Methotrexate (MTX) Combination Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 476
- 主要终点
- Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)
研究概览
简要总结
This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.
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
- •Adult patients, >/= 18 years of age
- •Diagnosis of rheumatoid arthritis by a rheumatologist
- •Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines
排除标准
- •Primary diagnosis of a condition other than rheumatoid arthritis
- •Current treatment with a biologic in combination without methotrexate
- •Prior treatment with an experimental agent for rheumatoid arthritis
结局指标
主要结局
Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)
时间窗: Month 6
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6.
次要结局
- Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment(Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment(Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.(Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Duration of Treatment(Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Average Methotrexate Dose of Participants on Biological Combination Treatment(Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.(Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment(Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))
- Percentage of Participants by Category of DAS28 Score and Timepoint(Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy))