N/A
Completed N=1,712
A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT04721808 ↗
Enrolled (actual)
1,712
Serious AEs
—
Results posted
Sep 2023
Primary outcomePrimary: Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators — 30.1; 29.5; 30.4 Percentage of participants
Summary
This study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with Rheumatoid Arthritis (RA) assessing real world patient data entered in the Corrona RA Registry on or after November 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
30.1; 29.5; 30.4 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
31.9; 33.1; 31.1 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy |
29.9; 35.7; 37.4; 26.7 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy |
31.9; 39.4; 39.0; 28.8 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose |
30.0; 34.6 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose |
34.0; 35.4 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation |
25.4; 30.1; 34.5 | — |
| PRIMARY Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation |
29.7; 32.9; 32.7 | — |
| SECONDARY Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
8.9; 8.8; 9.1; 10.1; 9.6; 10.4 | — |
| SECONDARY Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
-3.47; -2.96; -3.86; -3.46; -3.18; -3.67 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
-0.04; -0.03; -0.06; -0.06; -0.04; -0.07 | — |
| SECONDARY Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
-5.72; -4.92; -6.35; -5.69; -4.18; -6.84 | — |
| SECONDARY Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
-3.84; -2.37; -4.97; -3.36; -2.49; -4.01 | — |
| SECONDARY Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
21.4; 20.8; 21.9; 22.4; 21.2; 23.3 | — |
| SECONDARY Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
11.4; 11.2; 11.5; 10.4; 9.6; 11.0 | — |
| SECONDARY Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators |
5.3; 5.0; 5.5; 5.0; 5.7; 4.4 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy |
13.7; 13.7; 13.8; 15.5; 16.4; 14.7 | — |
| SECONDARY Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy |
18.7; 18.3; 19.1; 19.0; 17.5; 20.1 | — |
| SECONDARY Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy |
8.9; 13.6; 10.3; 7.4; 10.2; 20.9 | — |
| SECONDARY Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy |
-3.51; -4.36; -4.96; -2.85; -3.54; -4.45 | — |
| SECONDARY Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy |
-0.05; -0.05; -0.07; -0.04; -0.06; -0.06 | — |
| SECONDARY Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy |
-5.71; -8.03; -7.30; -4.77; -5.91; -7.09 | — |
| SECONDARY Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy |
-4.03; -6.73; -3.70; -3.53; -3.63; -5.46 | — |
| SECONDARY Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy |
21.3; 25.0; 24.5; 19.4; 22.4; 25.5 | — |
| SECONDARY Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy |
11.3; 12.3; 14.3; 10.2; 10.7; 15.5 | — |
| SECONDARY Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy |
5.1; 6.8; 7.6; 4.0; 5.1; 6.2 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy |
13.8; 18.0; 18.6; 11.5; 15.4; 22.4 | — |
| SECONDARY Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy |
18.6; 26.6; 22.7; 16.0; 19.0; 34.2 | — |
| SECONDARY Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose |
9.5; 10.3; 11.2; 10.3 | — |
| SECONDARY Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose |
-3.97; -3.43; -4.40; -2.77 | — |
| SECONDARY Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose |
-0.07; -0.03; -0.09; -0.03 | — |
| SECONDARY Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose |
-5.93; -6.53; -8.02; -3.79 | — |
| SECONDARY Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose |
-3.89; -3.65; -3.52; -2.84 | — |
| SECONDARY Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose |
23.4; 21.4; 24.2; 22.1 | — |
| SECONDARY Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose |
13.0; 11.7; 12.3; 9.7 | — |
| SECONDARY Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose |
5.6; 5.3; 5.3; 4.8 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose |
15.5; 14.4; 15.6; 18.2 | — |
| SECONDARY Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose |
20.7; 19.4; 21.1; 19.5 | — |
| SECONDARY Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation |
8.2; 9.0; 9.5; 9.4; 10.9; 9.2 | — |
| SECONDARY Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation |
-3.48; -3.48; -3.44; -4.43; -3.38; -2.59 | — |
| SECONDARY Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation |
-0.07; -0.02; -0.05; -0.12; -0.01; -0.07 | — |
| SECONDARY Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation |
-5.44; -5.13; -6.80; -8.16; -4.48; -5.27 | — |
| SECONDARY Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation |
-4.84; -3.04; -4.08; -4.98; -3.08; -2.15 | — |
| SECONDARY Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation |
24.3; 19.6; 21.5; 27.3; 19.4; 22.4 | — |
| SECONDARY Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation |
11.9; 10.6; 11.9; 12.2; 10.8; 7.8 | — |
| SECONDARY Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation |
5.3; 4.6; 6.2; 5.8; 5.2; 3.7 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation |
12.2; 14.6; 14.0; 12.6; 16.7; 16.5 | — |
| SECONDARY Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation |
15.8; 19.7; 20.0; 16.7; 20.6; 18.9 | — |
Eligibility Criteria
Inclusion Criteria
- Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012
- Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.
- Have CDAI measured at baseline
- Have at least a 6-month follow-up visit and CDAI measured at the 6-month follow-up visit
Exclusion Criteria
- There are no exclusion criteria for this study
Data sourced from ClinicalTrials.gov (NCT04721808). 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.