N/A
Completed N=318
A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT05487703 ↗
Enrolled (actual)
318
Serious AEs
—
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants According to Type of Health Insurance Plan — 210; 153; 147; 112 Participants
Summary
This study is to characterize the use of tofacitinib after use of rituximab in patients with Rheumatoid Arthritis in a real-world setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to Type of Health Insurance Plan |
210; 153; 147; 112; 20; 15 | — |
| PRIMARY Number of Participants With College Graduation or Higher Education |
206; 152 | — |
| PRIMARY Number of Participants According to Smoking Status |
149; 107; 110; 79; 55; 42 | — |
| PRIMARY Number of Participants According to Work Status |
84; 65; 19; 14; 24; 17 | — |
| PRIMARY Number of Participants According to Alcohol Use |
224; 171; 52; 35; 24; 15 | — |
| PRIMARY Number of Participants According to History of Comorbidities |
51; 36; 58; 40; 2; 1 | — |
| PRIMARY Duration of Rheumatoid Arthritis at Index Date |
17.5; 18.2 | — |
| PRIMARY Age at Onset of Rheumatoid Arthritis at Index Date |
42.3; 42.2 | — |
| PRIMARY Clinical Disease Activity Index (CDAI) |
23.1; 22.3 | — |
| PRIMARY Number of Participants According to CDAI Categories |
17; 13; 53; 38; 84; 64 | — |
| PRIMARY Tender Joint Count |
8.6; 8.3 | — |
| PRIMARY Swollen Joint Count |
5.5; 5.2 | — |
| PRIMARY Patient Global Assessment (PGA) VAS |
52.8; 51.4 | — |
| PRIMARY Modified Health Assessment Questionnaire (mHAQ) |
1.3; 1.3 | — |
| PRIMARY Pain VAS |
58.0; 57.1 | — |
| PRIMARY Fatigue VAS |
58.3; 57.3 | — |
| PRIMARY Number of Participants With European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Domain Scores of 2 or Higher |
229; 167; 161; 123; 232; 173 | — |
| PRIMARY Number of Participants According to Previous Drug Therapies With Conventional Disease-Modifying Antirheumatic Drug (csDMARD) |
7; 6; 69; 51; 242; 175 | — |
| PRIMARY Number of Participants According to Line of Therapy at Tofacitinib Initiation |
9; 9; 18; 15; 291; 208 | — |
| PRIMARY Number of Participants According to Concomitant Therapies |
147; 103; 85; 71; 55; 36 | — |
| PRIMARY Percentage of Participants Who Used Rituximab (RTX) Directly Before Tofacitinib |
36.9; 36.4 | — |
| PRIMARY Duration of Prior Rituximab (RTX) Use |
23.6; 22.8 | — |
| PRIMARY Number of Participants According to Line of Therapy at Rituximab Initiation |
33; 28; 64; 50; 98; 63 | — |
| PRIMARY Number of Participants According to Year of Rituximab Discontinuations |
7; 6; 20; 14; 42; 30 | — |
| PRIMARY Percentage of Participants Who Discontinued Rituximab |
34.3; 0 | — |
| PRIMARY Number of Participants According to Reason for Discontinuation of Rituximab |
60; 19; 6; 5; 19 | — |
| PRIMARY Number of Participants According to Tofacitinib Initiation Year |
81; 62; 80; 56; 83; 63 | — |
| PRIMARY Change From Baseline in CDAI at 6 Months Follow-up |
22.53; 19.08 | — |
| SECONDARY Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up |
28.6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months Follow-up |
1.35; 1.28 | — |
| SECONDARY Change From Baseline in Pain VAS at 6 Months Follow-up |
57.16; 51.27 | — |
| SECONDARY Change From Baseline in Fatigue VAS at 6 Months Follow-up |
57.39; 54.75 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05487703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.