Phase 2
Completed N=219
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT03963401 ↗Enrolled (actual)
219
Serious AEs
5.5%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16 — 43.28; 64.52; 66.67; 74.58 Percentage of participants — p=0.1172
Summary
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16 |
43.28; 64.52; 66.67; 74.58 | 0.1172 |
| SECONDARY Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve |
43.33; 64.29; 69.64; 74.55 | 0.0588 |
| SECONDARY Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52 |
21.67; 18.33; 18.75; 3.13; 5.88; 18.18 | — |
| SECONDARY Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
6.67; 1.67; 2.94; 3.13; 1.43; 1.47 | — |
| SECONDARY Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
3.33; 1.67; 2.94; 3.13; 1.43; 1.47 | — |
| SECONDARY Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-3.33; -2.7; -4.7; 0.0; -1.9; -2.1 | — |
| SECONDARY Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-2.3; -2.7; -4.6; -2.1; -2.0; -2.0 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-7.6; -8.0; -5.3; 1.7; -2.3; -9.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-6.3; -10.9; -5.4; 2.6; -0.1; -7.8 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-9.2; -9.0; -9.9; -1.9; -3.4; -7.2 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-0.133; -0.177; -0.195; -0.117; -0.030; -0.170 | — |
| SECONDARY Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-4.420; -3.696; -6.023; -0.595; -1.641; 1.462 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
5.00; 2.56; 3.85; 11.11; 2.17; 5.26 | — |
| SECONDARY Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
1.22; 1.25; 3.85; 11.11; 2.17; 2.50 | — |
| SECONDARY Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
1.22; 1.25; 3.85; 11.11; 2.17; 2.50 | — |
| SECONDARY Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-0.6; -0.3; -1.4; 0.0; -0.2; -0.3 | — |
| SECONDARY Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-0.4; -0.4; -0.5; 0.0; -0.1; -0.3 | — |
| SECONDARY Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-0.2; -0.7; -2.7; -0.5; -0.7; 0.2 | — |
| SECONDARY Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-0.4; 0.1; -0.4; 0.3; -0.2; 0.1 | — |
| SECONDARY Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-8.9; -11.6; -4.9; -0.5; -3.3; -7.1 | — |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
2.0; 3.1; 0.9; 1.2; 0.9; 2.7 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
3.29; 4.24; 2.59; 1.01; 1.66; 2.64 | — |
| SECONDARY Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
8.33; 8.33; 6.25; 3.13; 1.43; 3.03 | — |
| SECONDARY Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
0.82; 0.82; 2.94; 3.13; 1.43; 1.47 | — |
| SECONDARY Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-14.05; -13.99; -14.15; -9.81; -7.11; -9.08 | — |
| SECONDARY Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
50.00; 55.00; 50.00; 40.00; 26.47; 21.21 | — |
| SECONDARY Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 |
-1.22; -1.31; -0.94; -0.65; -0.56; -0.54 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities) |
46; 45; 10; 10; 24; 25 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related) |
17; 15; 6; 2; 11; 10 | — |
| SECONDARY Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56 |
0; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
- Active plaque psoriasis at screening and baseline.
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 (NCT03963401). 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.