Treatment Patterns and 6 and 12-Month Effectiveness of Tofacitinib in the Corrona Rheumatoid Arthritis Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,712
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
研究概览
简要总结
This study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with Rheumatoid Arthritis (RA) assessing real world patient data entered in the Corrona RA Registry on or after November 2012
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
- •Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012
- •Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.
- •Have CDAI measured at baseline
- •Have at least a 6-month follow-up visit and CDAI measured at the 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
Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
时间窗: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI=composite index for assessing disease activity (DA) based on summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any disease modifying antirheumatic drug \[DMARD\]) and by each line of therapy, second line: participants with prior use of at least 1 conventional synthetic (cs) DMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
时间窗: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI=composite index for assessing DA based on numerical summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy, second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose
时间窗: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg twice daily (BID) or 11 mg once daily (QD).
Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation
时间窗: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
时间窗: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count (TJC) and swollen joint count (\[SJC\] both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation
时间窗: At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).
Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
时间窗: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; between \>10 and \<=22 indicated moderate disease activity and \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose
时间窗: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg BID or 11 mg QD.
次要结局
- Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy(At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose(At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation(At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation(Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))
- Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation(Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study))