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

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

Official Title
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Tofacitinib Use in Rituximab-Experienced RA Patients

Conditions
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Arthritis, Rheumatoid

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical characteristics<br>clinical characteristics of adult patients with Rheumatoid Arthritis (RA) initiating tofacitinib | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of patients at tofacitinib initiation. | Describe characteristics of patients with history of rituximab exposure, initiating tofacitinib. | Baselline | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Number (%) of tofacitinib discontinuations prior to or at 6-month visit | Describe outcomes for tofacitinib initiators with a history of rituximab exposure. | 6 months |