Phase 3
N=394
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01882439 ↗Enrolled (actual)
394
Serious AEs
4.1%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3 — 49.62; 46.97; 23.66 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tofacitinib (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3 |
49.62; 46.97; 23.66 | <0.0001 sig |
| PRIMARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3 |
-0.3920; -0.3540; -0.1391 | <0.0001 sig |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 |
6.11; 9.85; NA; NA; 3.05; 17.56 | — |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 |
1.53; 2.27; NA; NA; 0.76; 5.34 | — |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6 |
26.72; 28.79; NA; NA; 12.98; 34.35 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 |
-0.2198; -0.1652; NA; NA; -0.0655; -0.3229 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3 |
-5.4657; -5.9156; 1.0233 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3 |
-21.66; -20.88; -7.72 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3 |
-21.59; -19.88; -7.14 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3 |
-27.25; -28.95; -15.88 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3 |
-7.6; -6.7; -2.7 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3 |
-9.9; -9.7; -4.5 | — |
| SECONDARY Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 |
32.82; 34.09; NA; NA; 17.56; 42.75 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6 |
-0.5; -0.8; NA; NA; -0.2; -0.7 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6 |
15.00; 18.52; NA; NA; 5.81; 21.25 | — |
| SECONDARY Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6 |
-2.8; -4.0; NA; NA; -1.1; -5.2 | — |
| SECONDARY Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6 |
-1.9; -1.9; NA; NA; -1.0; -2.5 | — |
| SECONDARY Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6 |
-1.0; -0.8; NA; NA; -0.5; -1.3 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6 |
4.65; 3.98; NA; NA; 1.70; 5.18 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6 |
4.09; 4.19; NA; NA; 2.33; 4.94 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6 |
3.97; 3.10; NA; NA; 1.55; 5.00 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6 |
4.22; 3.55; NA; NA; 2.24; 4.99 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6 |
6.86; 6.39; NA; NA; 2.31; 7.00 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6 |
3.24; 3.74; NA; NA; 2.29; 3.67 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6 |
4.52; 4.30; NA; NA; 1.73; 4.95 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6 |
4.93; 4.92; NA; NA; 2.33; 6.25 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6 |
4.44; 3.64; NA; NA; 3.25; 5.44 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6 |
3.80; 4.41; NA; NA; 1.73; 4.36 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6 |
-0.15; -0.10; NA; NA; -0.08; -0.17 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6 |
-0.11; -0.14; NA; NA; -0.03; -0.15 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6 |
-0.22; -0.19; NA; NA; -0.17; -0.23 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6 |
-0.26; -0.25; NA; NA; -0.11; -0.32 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6 |
-0.13; -0.21; NA; NA; -0.10; -0.19 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6 |
9.76; 9.58; NA; NA; 3.59; 8.62 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6 |
6.0; 4.4; NA; NA; 2.2; 7.0 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6 |
2.7; 2.3; NA; NA; 1.0; 3.1 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6 |
3.3; 2.1; NA; NA; 1.2; 3.9 | — |
| SECONDARY Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6 |
-2.04; -1.26; NA; NA; -0.34; -2.26 | — |
Summary
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
Eligibility Criteria
Inclusion Criteria
- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
- Active plaque psoriasis at screening
- Inadequate efficacy or lack of toleration to previously administered TNF inhibitor
Exclusion Criteria
- Non-plaque forms of psoriasis (with exception of nail psoriasis)
- History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
Data sourced from ClinicalTrials.gov (NCT01882439). 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.