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

Arthritis, Rheumatoid Clinical Trial

Official title:

Tofacitinib Use in Rituximab-Experienced RA Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487703
• Other study ID #: A3921420
• Status: Completed
• Start date: November 14, 2022
• Est. completion date: December 23, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
Morocco	Pfizer	Casablanca

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of patients at tofacitinib initiation.	Describe characteristics of patients with history of rituximab exposure, initiating tofacitinib.	Baselline
Primary	Change in Clinical Disease Activity Index (CDAI)	Describe outcomes for tofacitinib initiators with a history of rituximab exposure.; CDAI is the numerical sum of four outcome parameters: tender joint count (TJC) and swollen joint count (SJC) both based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.	6 months
Secondary	Achievement of Minimum Clinically Important Difference (MCID)	Describe outcomes for tofacitinib initiators with a history of rituximab exposure.; MCID improvement assessed based on Clinical disease activity index (CDAI). CDAI: numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 centimeter (cm) Visual analogue scale (VAS); CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI =2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate DA, and >22 indicates high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6-month visit. Participants were considered to show improvement from baseline on 3 cut points (1) greater than 1 (for participants in low DA at baseline); (2) > 6 (moderate DA at baseline, and (3) > 12 (high DA at baseline). Here, overall number of participants who showed improvement have been reported.	6 months
Secondary	Change in HAQ (Health Assessment Questionnaire)	Describe outcomes for tofacitinib initiators with a history of rituximab exposure.; The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status.	6 months
Secondary	Change in patient pain (Visual analogue scale VAS range 0-100)	Describe outcomes for tofacitinib initiators with a history of rituximab exposure.; Patient self-reported assessment of the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.	6 month
Secondary	Change in patient fatigue (Visual analogue scale VAS range 0-100)	Describe outcomes for tofacitinib initiators with a history of rituximab exposure.; Patient self-reported assessment of the severity of their arthritis fatigue using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no fatigue) and 100 (most severe fatigue), which corresponds to the magnitude of their fatigue.	6 months
Secondary	Number (%) of tofacitinib discontinuations prior to or at 6-month visit	Describe outcomes for tofacitinib initiators with a history of rituximab exposure.	6 months

External Links

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