Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9,159
- 试验地点
- 1
- 主要终点
- Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
研究概览
简要总结
To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib
排除标准
- •Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses
- •Patients using combination therapy with a cDMARD other than MTX will be excluded
- •Patients using combination therapy of MTX and another cDMARD will be excluded
结局指标
主要结局
Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
时间窗: At month 6 follow up visit
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
次要结局
- Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012(At baseline)
- CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX(At month 6 follow up visit)
- Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation(At baseline)
- CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX(At month 6 follow up visit)
- Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012(At baseline)
- CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy(At month 6 follow up visit)
- Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation(At baseline)
- CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX(At month 6 follow up visit)
- CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy(At month 6 follow up visit)
- Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX(At month 6 follow up visit)
- Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX(At month 6 follow up visit)
- Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX(At month 6 follow up visit)
- Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy(At month 6 follow up visit)
- Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX(At month 6 follow up visit)
- Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy(At month 6 follow up visit)
- Number of Participants According to Line of Therapy at TNFi Initiation(At baseline)
- Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012(At baseline)
- Number of Participants According to Line of Therapy at Tofacitinib Initiation(At baseline)
- Median CDAI Score at Baseline- TNFi Initiator(At baseline)
- Median CDAI Score at Baseline- Tofacitinib Initiator(At baseline)