IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 314
- 试验地点
- 52
- 主要终点
- Duration of Tofacitinib Drug Survival
研究概览
简要总结
Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.
Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.
As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.
详细描述
This is an observational, open-label, prospective, multi-centre, national study designed to evaluate the factors predictive of Tofacitinib's survival in patients with rheumatoid arthritis
If catastrophisation is described as a distortion of the perception of pain involving a both emotional and cognitive component, pushing the patient to see only the worst, coping involves adaptive strategies by which the patient attempts to find solutions in order to better cope with his/her disease. It has been demonstrated that such behavioural strategies can influence directly or indirectly the intensity of symptoms in patients suffering from chronic disease.
Therefore, as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.
The duration of this study will be approximately 48 months including a 24-month recruitment period and a 24-month patient follow-up period.
Patients will be followed prospectively and follow-up visits will be conducted after the initial consultations. No visit or additional test is required by the protocol, since the study is observational
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
- •Patient 18 years of age or older
- •Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist
- •Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib
- •Patient informed of the study
排除标准
- •Patient participating in a randomised clinical trial.
- •Patient presenting with a contraindication to prescription of Tofacitinib
- •Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
研究组 & 干预措施
Rheumatoid arthritis
All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Duration of Tofacitinib Drug Survival
时间窗: Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)
The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.
次要结局
- Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18 and 24)
- Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6 12, 18 and 24)
- Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2)(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2)(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants With Remission According to DAS28-4 ESR<2.6(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants With Remission According to DAS28-4 CRP <2.6(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants in Remission According to SDAI <=3.3(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants in Remission According to CDAI<=2.8(Baseline, Month 1, 3, 6, 12 18, and 24)
- Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria(Baseline, Month 1, 3, 6, 12 18, and 24)
- Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18, and 24)
- Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18, and 24)
- Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)(Month 1, 3, 6, 12, 18, and 24)
- Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18, and 24)
- Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18, and 24)
- Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response(Baseline, Month 1, 3, 6, 12, 18 and 24)
- Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18 and 24)
- Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24(Month 1, 3, 6, 12, 18 and 24)
- Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18 and 24)
- Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18 and 24)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24(Baseline, Month 1, 3, 6, 12, 18 and 24)
- Number of Participants With Tofacitinib Tolerance Issue(Month 24)