Phase 3
N=209
A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02281552 ↗Enrolled (actual)
209
Serious AEs
4.3%
Results posted
Oct 2018
Primary outcome: Primary: Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 — -2.43; -2.85 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tofacitinib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 |
-2.43; -2.85 | — |
| SECONDARY Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 |
-2.50; -2.86 | — |
| SECONDARY Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 |
87; 83 | — |
| SECONDARY Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 |
70; 71 | — |
| SECONDARY Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 |
32; 48 | — |
| SECONDARY Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 |
52; 72 | — |
| SECONDARY Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12 |
18; 36 | — |
| SECONDARY Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12 |
76; 82 | — |
| SECONDARY Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12 |
44; 63 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 |
-0.44; -0.46 | — |
| SECONDARY Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12 |
65; 60 | — |
| SECONDARY Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 |
5.54; 6.29; 6.51; 6.97; 9.41; 11.92 | — |
| SECONDARY Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 |
6.59; 7.85; 5.29; 5.08 | — |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12 |
5.28; 6.12 | — |
| SECONDARY Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12 |
0.20; 0.25 | — |
Summary
This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.
Eligibility Criteria
Inclusion Criteria
- diagnosis of rheumatoid arthritis
- currently taking a stable dose of methotrexate
- no evidence of active or latent or inadequately treated tuberculosis
Exclusion Criteria
- evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
- clinically significant infections within the past 6 months
Data sourced from ClinicalTrials.gov (NCT02281552). 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.