N/A
Completed N=298
A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day
Arthritis Rheumatoid
Source: ClinicalTrials.gov NCT04267380 ↗
Enrolled (actual)
298
Serious AEs
—
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months — 38; 33 Participants — p=0.73
Summary
It is hypothesized that patients prescribed tofacitinib 11 mg Modified Release (MR) formulation once daily (QD) will achieve similar benefit to those prescribed tofacitinib 5 mg twice a day (BID) dosage in real world use. This study will therefore seek to compare the effectiveness of the MR 11 mg QD regimen to the IR 5 mg BID regimen for the treatment of RA in a real-world registry of RA patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months |
38; 33 | 0.73 |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 |
16.4; 17.9; -2.19; -2.12 | 0.97 |
| SECONDARY Number of Participants Achieving Remission at Month 6 (All Participants) |
13; 8 | 0.26 |
| SECONDARY Number of Participants Achieving Remission at Month 6 (For Participants With Baseline CDAI >2.8) |
8; 4 | 0.23 |
| SECONDARY Number of Participants Achieving Low Disease Activity at Month 6 (All Participants) |
54; 46 | 0.33 |
| SECONDARY Number of Participants Achieving Low Disease Activity at Month 6 (Participants With Baseline CDAI >10) |
28; 17 | 0.07 |
| SECONDARY Number of Participants With Decrease From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 |
24; 26 | 0.68 |
| SECONDARY Number of Participants With Decrease From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 |
24; 27 | 0.68 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6: Dichotomous Variable |
— | — |
| SECONDARY Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 |
-0.02; -0.06 | 0.45 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 |
-0.03; -0.07 | 0.53 |
| SECONDARY Change From Baseline in Modified Disease Activity Score Based on 28-joints Count (mDAS28) at Month 6 |
4.1; 4.2; -0.23; -0.20 | 0.86 |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) Erythrocyte Sedimentation Rate (ESR) at Month 6 |
3.9; 4.0; -0.17; -0.10 | 0.83 |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) C- Reactive Protein (CRP) at 6 Month |
3.6; 3.9; -0.22; -0.33 | 0.67 |
| SECONDARY Change From Baseline in Participant Pain Score at Month 6 |
48.2; 48.3; -1.30; -0.78 | 0.86 |
| SECONDARY Change From Baseline in Participant Fatigue Score at Month 6 |
48.6; 50.6; -0.04; -0.86 | 0.78 |
| SECONDARY Change From Baseline in European Quality of Life- 5 Dimension (EQ-5D) Index at Month 6 |
0.7; 0.7; 0.00; 0.00 | 0.99 |
| SECONDARY Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response |
14; 23 | 0.11 |
| SECONDARY Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response |
8; 10 | 0.63 |
| SECONDARY Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response |
5; 2 | 0.25 |
Eligibility Criteria
Inclusion Criteria
- All US Corrona RA Registry patients who initiated tofacitinib 5 mg twice a day (BID) or tofacitinib 11 mg once daily (QD) after it became available in February 2016
- Patients must have a follow-up visit at 6 months (+/- 3 months) after tofacitinib initiation. These 6 month visits are part of routine practice and is not associated with this protocol.
- Patients must have a valid clinical disease activity index (CDAI) at initiation and at 6-month follow-up visit
Exclusion Criteria
- There are no exclusion criteria for this study.
Data sourced from ClinicalTrials.gov (NCT04267380). 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.