Clinical trial NCT04721808: A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis
Official title: Treatment Patterns and 6 and 12-Month Effectiveness of Tofacitinib in the Corrona Rheumatoid Arthritis Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 1712
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from the Corrona RA Registry. The Corrona registry is a prospective, multicenter, observational disease-based registry launched in 2001.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: 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
timeFrame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
timeFrame: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
timeFrame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
timeFrame: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose
timeFrame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose
timeFrame: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation
timeFrame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation
timeFrame: At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study)
Secondary outcomes:
measure: Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
timeFrame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
timeFrame: 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)
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
timeFrame: 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)
measure: 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
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: 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
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: 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
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: 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
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
timeFrame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
timeFrame: 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)
measure: Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
timeFrame: 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)
measure: Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
timeFrame: 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)
measure: Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
timeFrame: 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)
measure: Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose
timeFrame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose
timeFrame: 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)
measure: Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose
timeFrame: 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)
measure: Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose
timeFrame: 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)
measure: Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose
timeFrame: 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)
measure: Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
timeFrame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
timeFrame: 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)
measure: Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
timeFrame: 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)
measure: Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
timeFrame: 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)
measure: Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
timeFrame: 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)
measure: Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: 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
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
measure: Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
timeFrame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: