A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clinical characteristics clinical characteristics of adult patients with Rheumatoid Arthritis (RA) initiating tofacitinib |
Outcome Measures
Primary Outcome Measures
- Characterization of patients at tofacitinib initiation. [Baselline]
Describe characteristics of patients with history of rituximab exposure, initiating tofacitinib.
- Change in Clinical Disease Activity Index (CDAI) [6 months]
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.
Secondary Outcome Measures
- Achievement of Minimum Clinically Important Difference (MCID) [6 months]
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.
- Change in HAQ (Health Assessment Questionnaire) [6 months]
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.
- Change in patient pain (Visual analogue scale VAS range 0-100) [6 month]
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.
- Change in patient fatigue (Visual analogue scale VAS range 0-100) [6 months]
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.
- Number (%) of tofacitinib discontinuations prior to or at 6-month visit [6 months]
Describe outcomes for tofacitinib initiators with a history of rituximab exposure.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Enrolled in the CorEvitas RA Registry and initiated tofacitinib on or after November
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Initiate tofacitinib (defined as first ever use of tofacitinib) at Registry enrollment visit or at a Registry follow-up visit after November 2012
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Have prior use of rituximab
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Have CDAI measured at baseline and appropriate follow-up visit.
Exclusion Criteria:
- There are no exclusion criteria for this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | Casablanca | Morocco |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A3921420