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

NCT05487703 | Completed Results

• 1 other identifier: A3921420
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (28)

• 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 Outcomes (4)

• Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up

  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

  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

  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

  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])

Study Arms (1)

Clinical characteristics

clinical characteristics of adult patients with Rheumatoid Arthritis (RA) initiating tofacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Casablanca, Morocco

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: November 14, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)