A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting

Tofacitinib Use in Rituximab-Experienced RA Patients

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• Morocco
  • Casablanca, Morocco
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This will be a retrospective analysis of participants data using the CorEvitas RA Registry

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Clinical characteristics; clinical characteristics of adult patients with Rheumatoid Arthritis (RA) initiating tofacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants According to Type of Health Insurance Plan	Number of participants according to type of health insurance plan was reported in this outcome measure. The health insurance plan included private, Medicare, Medicaid and no insurance. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one type of insurance.	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)
Number of Participants With College Graduation or Higher Education	Number of participants who were college graduate or had higher education were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Smoking Status	Number of participants according to smoking status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Work Status	Number of participants according to work status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Alcohol Use	Number of participants according to alcohol use were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to History of Comorbidities	Number of participants according to history of comorbidities were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one history of comorbidities.	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)
Duration of Rheumatoid Arthritis at Index Date	Duration of rheumatoid arthritis in participants at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Age at Onset of Rheumatoid Arthritis at Index Date	Participants age at onset of rheumatoid arthritis at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Clinical Disease Activity Index (CDAI)	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. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to CDAI Categories	Number of participants according to CDAI category were reported in this outcome measures. CDAI was simplified index for assessing disease activity comprising of SJC, TJC, PtGA and PGA. CDAI is numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher score indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm VAS; higher score indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher score indicated worse condition. Score range-Remission: CDAI less than or equal to (<=) 2.8. Low Disease Activity: CDAI greater than (>) 2.8 and <= 10. Moderate Disease Activity: CDAI > 10 and <= 22. High Disease Activity: CDAI > 22. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Tender Joint Count	Tender joint count was used to measure the pain and inflammation in the joints, based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Swollen Joint Count	Swollen joint count was used to measure the pain and inflammation in the joints. Based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Patient Global Assessment (PGA) VAS	PGA-VAS was used to assess disease activity; assessed on 0-100 millimeter (mm) VAS; higher scores indicated greater affection due to disease activity. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Modified Health Assessment Questionnaire (mHAQ)	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicated worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Pain VAS	Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Fatigue VAS	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants With European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Domain Scores of 2 or Higher	EQ-5D-3L is a health profile questionnaire used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (walking, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicated more severe problems. In this outcome measure number of participants with a domain score of 2 or higher in each individual domain are reported. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Previous Drug Therapies With Conventional Disease-Modifying Antirheumatic Drug (csDMARD)	Number of participants according to previous drug therapies with csDMARD were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Line of Therapy at Tofacitinib Initiation	Number of participants were classified according to line of therapy in which Tofacitinib was initiated and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Concomitant Therapies	Number of participants classified according to concomitant therapies were reported in this outcome measure. One participant might have received more than one concomitant therapy. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Percentage of Participants Who Used Rituximab (RTX) Directly Before Tofacitinib	Percentage of participants who used rituximab directly before tofacitinib were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Duration of Prior Rituximab (RTX) Use	Duration of prior RTX use (in months) was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Line of Therapy at Rituximab Initiation	Number of participants were classified according to line of therapy in which Rituximab was initiated were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Year of Rituximab Discontinuations	Number of participants were classified according to year of rituximab discontinuations and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Percentage of Participants Who Discontinued Rituximab	Percentage of participants who discontinued rituximab were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Reason for Discontinuation of Rituximab	Number of participants were classified according to reasons for discontinuation of rituximab and were reported in this outcome measure. Reasons for discontinuation of rituximab included safety, effectiveness, insurance, participant doing well and other reasons. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Number of Participants According to Tofacitinib Initiation Year	Number of participants were classified according to year of tofacitinib initiation and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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)
Change From Baseline in CDAI at 6 Months Follow-up	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; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up	MCID improvement was assessed based on health assessment questionnaire (HAQ). HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total score ranged from 0 to 3, where 0= least difficulty and 3= extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for HAQ was defined as decrease in minimum of 0.22 units from baseline. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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])
Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months Follow-up	HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, hygiene, reaching, griping, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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])
Change From Baseline in Pain VAS at 6 Months Follow-up	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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])
Change From Baseline in Fatigue VAS at 6 Months Follow-up	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.	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])

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: A3921420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.