BASELINE VARIABLES PREDICTING TREATMENT RESPONSE AT 6 MONTHS IN ADULT RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB 5MG BID IN A NON-INTERVENTIONAL SETTING (TREAT - RA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 198
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP)
研究概览
简要总结
This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece.
The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented.
The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site
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
- •Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label
- •Patients aged ≥ 18 years
- •Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
- •Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days .
- •Patients eligible for tofacitinib treatment according to current approved 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
- •Patients meeting any of the following criteria will not be included in the study:
- •Exclusion Criteria according to the Xeljanz® SmPC.
- •Contraindications to Xeljanz® according to SmPC.
- •Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
- •Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
- •Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.
- •Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
- •Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
结局指标
主要结局
Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP)
时间窗: Month 6
Remission is defined as DAS28-4 CRP less than (\<) 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: tender joint count (TJC) and swollen joint count ((SJC) \[both out of 28 evaluated joints\], CRP milligram per liter (mg/l) and Patient's Global Assessment of Arthritis Disease Activity (PtGA) recorded on 100 millimeter (mm) visual analogue scale (VAS) (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm.
次要结局
- Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP)(Baseline, Months 3, 6 and 12)
- Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP(Month 12)
- Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12(Months 3, 6 and 12)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12(Baseline, Months 3, 6 and 12)
- Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12(Months 3, 6 and 12)
- Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12(Months 3, 6 and 12)
- Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12(Months 3, 6 and 12)
- Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12(Months 3, 6 and 12)
- Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12(Months 3, 6 and 12)
- Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12(Months 3, 6 and 12)
- Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12(Months 3, 6 and 12)
- Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12(Months 3, 6 and 12)
- Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12(Baseline, Months 3, 6 and 12)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12(Baseline, Months 3, 6 and 12)
- Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12(Baseline, Day 1 and 2 of Months 3, 6 and 12)
- Percentage of Participants With Treatment Satisfaction at Baseline and Month 12(Baseline, Month 12)
- Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12(Baseline, Months 3, 6 and 12)
- Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12(Baseline, Months 3, 6 and 12)
- Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit(Months 3, 6 and 12)
- Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12(Baseline, Months 3, 6 and 12)
- Number of Participants as Per Treatment Received(Up to 12 months)
- Number of Diagnostic Tests Since Last Visit(Months 3, 6 and 12)
- Number of Participants With Diagnostic Test Since Last Visit(Months 3, 6 and 12)
- Number of Participants According to the Type of Diagnostic Test(Months 3, 6 and 12)
- Number of Participants Hospitalized Since Last Visit(Months 3, 6 and 12)
- Number of Participants Hospitalized in Daycare and Night Care Since Last Visit(Months 3, 6 and 12)
- Mean Number of Days Participants Were Hospitalized Since Last Visit(Baseline, Months 3, 6 and 12)
- Number of Participants According to Reason for Hospitalization Since Last Visit(Months 3, 6 and 12)