NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ (Registered))
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 73
- 试验地点
- 6
- 主要终点
- CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)
研究概览
简要总结
12-month, single arm, prospective, non-interventional, multi-center study according to Czech legal definitions (Law 378/2007 Sb.).The primary objective of this study is to describe and evaluate the changes of depression level within 12 months from the start of tofacitinib therapy in patients with RA and at least minimal level of depression. Primary goal is to find out if treatment by tofacitinib reduces the depression by at least 10% during 12 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
- •Patients aged ≥18 years.
- •Moderate to severe activity of rheumatoid arthritis (DAS28 ≥3.2).
- •Patient for whom the physician decision has been made to initiate a treatment with Tofacitinib.
- •Patient with at least minimal level of depression (CUDOS questionnaire ≥11 points).
- •Capable of understanding and signing a written informed consent form.
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.
排除标准
- •Patients unwilling/unable to fill in printed patient questionnaires.
结局指标
主要结局
CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)
时间窗: Baseline (Visit 1), 12 Months (Visit 3)
The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
次要结局
- CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2)(Baseline (Visit 1), 6 Months (Visit 2))
- CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1)(Baseline (Visit 1), 12 Months (Visit 3))
- Absolute Change From Baseline in DAS28-4 (CRP) at 6 Months (Visit 2) and 12 Months (Visit 3)(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- Change From Baseline in EuroQol Five Dimension - 3 Level (EQ-5D-3L) Health State Profile at 6 Months (Visit 2) and 12 Months (Visit 3)(Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From start of study treatment to 12 months post treatment initiation)