A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12
研究概览
简要总结
This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.
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
- •Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).
排除标准
- •Participants previously or currently treated with RoActemra/Actemra in clinical trials
- •Absolute neutrophil count less than or equal to (</=) 2x10^9 per liter (/L)
研究组 & 干预措施
Rheumatoid Arthritis Participants
Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center will be followed-up for 6 months.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12
时间窗: Week 12
Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24
时间窗: Week 24
Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
次要结局
- Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24(Week 12, 24)
- Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24(Baseline, Week 12, 24)
- Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24(Baseline, Week 12, 24)
- Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24(Week 12, 24)
- Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F(Baseline, Week 12, Week 24)
- Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population(Baseline, Week 12, 24)
- Change From Baseline to Week 12 and 24 in Serum Hemoglobin(Baseline, Week 12, 24)
- Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population(Week 12, 24)
- Change From Baseline in Duration of Morning Stiffness at Week 12, 24(Baseline, Week 12, 24)
- Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24(Baseline, Week 12, 24)
- Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24(Baseline, Week 12, 24)
- Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population(Baseline, Week 12, 24)
- Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24(Week 12, 24)
- Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population(Baseline, Week 12, 24)
- Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population(Baseline, Week 12, 24)
- Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population(Baseline, Week 12, 24)
- Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population(Week 12, 24)
- Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24(Baseline, Week 12, Week 24)
- Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population(Baseline, Week 12, 24)
- Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population(Week 12, 24)