Phase 3
Completed N=851
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
Source: ClinicalTrials.gov NCT02376790 ↗Enrolled (actual)
851
Serious AEs
6.1%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 — 50.7; 60.9; 65.0 percentage of participants — p=0.005
◆ Published Evidence
Highly cited
216citations · ~31 / year
Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial.
Summary
The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.
Linked Publications (2)
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Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial.
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Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 |
50.7; 60.9; 65.0 | 0.005 sig |
| SECONDARY Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 |
22.9; 35.9; 35.7 | 0.005 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time |
25.0; 44.3; 46.4; 46.5; 60.2; 60.8 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time |
6.0; 16.5; 18.8; 15.1; 31.3; 30.1 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time |
2.8; 3.6; 5.1; 4.4; 15.2; 14.5 | <0.001 sig |
| SECONDARY Change From Baseline in Tender Joint Count Over Time |
-5.7; -6.4; -7.4; -7.8; -8.9; -9.4 | — |
| SECONDARY Change From Baseline in Swollen Joint Count Over Time |
-4.1; -4.8; -4.7; -5.4; -6.2; -6.5 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity Over Time |
-16.8; -23.1; -22.8; -25.0; -29.7; -30.4 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity Over Time |
-11.0; -21.9; -21.0; -15.6; -27.3; -26.4 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Joint Pain Over Time |
-8.9; -18.4; -18.5; -14.5; -23.5; -24.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time |
-0.188; -0.266; -0.306; -0.277; -0.365; -0.403 | — |
| SECONDARY Change From Baseline in C-reactive Protein Concentration Over Time |
-0.93; -5.91; -5.49; -2.31; -7.51; -5.19 | — |
| SECONDARY Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time |
5.7; 11.1; 12.6; 3.0; 9.4; 7.4 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time |
-1.63; -2.32; -2.37; -1.98; -2.64; -2.63 | <0.001 sig |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time |
-8.38; -10.59; -10.68; -11.56; -14.13; -14.56 | 0.59 |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time |
-8.38; -11.12; -11.18; -11.77; -14.92; -15.14 | 0.41 |
| SECONDARY Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time |
-0.73; -1.18; -1.21; -1.05; -1.64; -1.61 | 0.010 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24 |
-0.412; -0.444; -0.468 | 0.34 |
| SECONDARY Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24 |
5.952; 7.808; 8.011; 3.259; 2.835; 3.321 | 0.015 sig |
| SECONDARY Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 |
-1.1; -1.5; -1.7 | 0.020 sig |
| SECONDARY Percentage of Participants With Clear mNAPSI at Week 24 |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Leeds Dactylitis Index (LDI) at Week 24 |
-128.80; -119.09; -110.15 | 0.68 |
| SECONDARY Percentage of Participants With Clear LDI at Week 24 |
65.2; 76.4; 79.3 | 0.057 |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24 |
-3.1; -3.0; -2.9 | 0.70 |
| SECONDARY Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24 |
43.1; 52.6; 47.8 | 0.55 |
| SECONDARY Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24 |
66.12; 69.80; 75.53 | 0.031 sig |
| SECONDARY Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups |
-24.49; -92.18; 17.66; 66.61; 64.42; 68.76 | <0.001 sig |
| SECONDARY Static Physician Global Assessment (sPGA) at Week 24 |
38; 36; 63; 80; 84; 62 | — |
| SECONDARY Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups |
26; 29; 52; 28; 37; 32 | — |
| SECONDARY Mean Static Physician Global Assessment (sPGA) Score at Week 24 |
1.3; 1.2; 0.9 | — |
| SECONDARY Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups |
1.0; 1.1; 0.6; 1.1; 1.3; 0.9 | — |
| SECONDARY Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 |
66.3; 72.3; 77.6 | 0.019 sig |
| SECONDARY Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups |
72.0; 71.7; 87.5; 73.6; 64.0; 76.3 | 0.004 sig |
| SECONDARY Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 |
29.9; 28.9; 18.0 | — |
| SECONDARY Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups |
37.0; 44.6; 43.8; 27.9; 38.7; 21.1 | — |
| SECONDARY Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 |
30.5; 28.9; 35.4 | — |
| SECONDARY Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups |
15.1; 20.7; 30.2; 34.9; 25.3; 32.9 | — |
Eligibility Criteria
Key Inclusion Criteria
- Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
- Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.
- Subject has an active psoriatic skin lesion
- Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis.
- Subject has no prior use of methotrexate for PsA.
- Subject has no history of tuberculosis
- Subject has a negative test for tuberculosis, hepatitis B and C.
Exclusion Criteria
- Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.
- Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
- Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.
Data sourced from ClinicalTrials.gov (NCT02376790) 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.