Clinical trial NCT05487703: A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting
Official title: Tofacitinib Use in Rituximab-Experienced RA Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a retrospective analysis of participants data using the CorEvitas RA Registry

Brief summary: This study is to characterize the use of tofacitinib after use of rituximab in patients with Rheumatoid Arthritis in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the CorEvitas RA Registry and initiated tofacitinib on or after November 2012.
* Initiate tofacitinib (defined as first ever use of tofacitinib) at Registry enrollment visit or at a Registry follow-up visit after November 2012
* Have prior use of rituximab
* Have CDAI measured at baseline and appropriate follow-up visit.

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Number of Participants According to Type of Health Insurance Plan
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants With College Graduation or Higher Education
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Smoking Status
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Work Status
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Alcohol Use
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to History of Comorbidities
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Duration of Rheumatoid Arthritis at Index Date
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Age at Onset of Rheumatoid Arthritis at Index Date
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Clinical Disease Activity Index (CDAI)
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to CDAI Categories
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Tender Joint Count
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Swollen Joint Count
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Patient Global Assessment (PGA) VAS
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Modified Health Assessment Questionnaire (mHAQ)
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Pain VAS
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Fatigue VAS
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants With European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Domain Scores of 2 or Higher
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Previous Drug Therapies With Conventional Disease-Modifying Antirheumatic Drug (csDMARD)
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Line of Therapy at Tofacitinib Initiation
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Concomitant Therapies
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Percentage of Participants Who Used Rituximab (RTX) Directly Before Tofacitinib
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Duration of Prior Rituximab (RTX) Use
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Line of Therapy at Rituximab Initiation
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Year of Rituximab Discontinuations
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Percentage of Participants Who Discontinued Rituximab
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Reason for Discontinuation of Rituximab
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Number of Participants According to Tofacitinib Initiation Year
timeFrame: At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)
measure: Change From Baseline in CDAI at 6 Months Follow-up
timeFrame: Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])
Secondary outcomes:
measure: Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up
timeFrame: Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months Follow-up
timeFrame: Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])
measure: Change From Baseline in Pain VAS at 6 Months Follow-up
timeFrame: Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])
measure: Change From Baseline in Fatigue VAS at 6 Months Follow-up
timeFrame: Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])
Other outcomes:
Locations:
city: Casablanca
country: Morocco
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: