Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02281552 ↗Enrolled (actual)
209
Serious AEs
4.3%
Results posted
Oct 2018
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
163citations · ~54 / year
Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial.
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.
Linked Publications (5)
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Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial.
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Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance.
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Fracture in clinical studies of tofacitinib in rheumatoid arthritis.
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Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study.
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Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs.
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 | — |
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) and the linked publication. 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.