Compare Effectiveness of Tofacitinib 11 mg QD to Tofacitinib 5 mg BID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months
研究概览
简要总结
It is hypothesized that patients prescribed tofacitinib 11 mg Modified Release (MR) formulation once daily (QD) will achieve similar benefit to those prescribed tofacitinib 5 mg twice a day (BID) dosage in real world use. This study will therefore seek to compare the effectiveness of the MR 11 mg QD regimen to the IR 5 mg BID regimen for the treatment of RA in a real-world registry of RA patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All US Corrona RA Registry patients who initiated tofacitinib 5 mg twice a day (BID) or tofacitinib 11 mg once daily (QD) after it became available in February 2016
- •Patients must have a follow-up visit at 6 months (+/- 3 months) after tofacitinib initiation. These 6 month visits are part of routine practice and is not associated with this protocol.
- •Patients must have a valid clinical disease activity index (CDAI) at initiation and at 6-month follow-up visit
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months
时间窗: Baseline Up to 6 Months
MCID improvement assessed based on Clinical disease activity index (CDAI). CDAI: numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 centimeter (cm) Visual analogue scale (VAS); CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI less than or equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low DA, \>10 to 22 = moderate DA, and \>22 = high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6 month visit. Participants were considered to show improvement from baseline on 3 cut points (1) greater than or equal (\>=) to 2 (for participants in low DA at baseline); (2) \>= 6 (moderate DA at baseline, and (3) \>= 11 (high DA at baseline). Here, overall number of participants who showed improvement have been reported.
次要结局
- Number of Participants Achieving Low Disease Activity at Month 6 (All Participants)(Month 6)
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6: Dichotomous Variable(Baseline, Month 6)
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6(Baseline, Month 6)
- Change From Baseline in Participant Pain Score at Month 6(Baseline, Month 6)
- Change From Baseline in Participant Fatigue Score at Month 6(Baseline, Month 6)
- Number of Participants Achieving Remission at Month 6 (All Participants)(Month 6)
- Number of Participants Achieving Remission at Month 6 (For Participants With Baseline CDAI >2.8)(Month 6)
- Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) Erythrocyte Sedimentation Rate (ESR) at Month 6(Baseline, Month 6)
- Number of Participants With Decrease From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6(Month 6)
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6(Baseline, Month 6)
- Number of Participants Achieving Low Disease Activity at Month 6 (Participants With Baseline CDAI >10)(Month 6)
- Number of Participants With Decrease From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6(Month 6)
- Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6(Baseline, Month 6)
- Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) C- Reactive Protein (CRP) at 6 Month(Baseline, 6 months)
- Change From Baseline in European Quality of Life- 5 Dimension (EQ-5D) Index at Month 6(Baseline, Month 6)
- Change From Baseline in Modified Disease Activity Score Based on 28-joints Count (mDAS28) at Month 6(Baseline, Month 6)
- Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response(Month 6)
- Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response(Month 6)
- Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response(Month 6)