ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,459
- 试验地点
- 87
- 主要终点
- Number of Participants With Treatment Escalations
研究概览
简要总结
This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.
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
- •Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
- •Patient is eligible for Tofacitinib treatment according to Summary of Product Characteristics (SmPC)
- •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.
排除标准
- •Contraindications according to Xeljanz® SmPC
- •Receipt of any investigational drug within 3 months before study inclusion
- •Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors
- •Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.
结局指标
主要结局
Number of Participants With Treatment Escalations
时间窗: From date of first prescription of tofacitinib up to 24 Months
Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.
Time to Treatment Escalation
时间窗: From date of first prescription of tofacitinib up to 24 Months
Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.
次要结局
- Time to First Step Up Treatment Escalation(From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months))
- Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24(Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24(Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24(Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24(Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24(Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24(Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Mean Number of Days of Drug Survival at Months 12 and 24(At 12 and 24 months)
- Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24(Months 3, 6, 9, 12, 15, 18, 21 and 24)