Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Methotrexate; Drug: Placebo to Etanercept; Drug: Etanercept; Drug: Placebo to Methotrexate

Detailed Description

The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period.

At or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.

• Study Type: Interventional
• Enrollment (Actual): 851
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Research Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1015ABO
      • Research Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
      • Research Site
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Research Site
  • Pleven, Bulgaria, 5800
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  • Plovdiv, Bulgaria, 4002
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  • Rouse, Bulgaria, 7002
    • Research Site
  • Sofia, Bulgaria, 1784
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  • Sofia, Bulgaria, 1612
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• Canada
  • Quebec, Canada, G1V 3M7
    • Research Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3N 0K6
      • Research Site
  • Ontario
    • London, Ontario, Canada, N6A 3H7
      • Research Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Research Site
  • Quebec
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Research Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 3H3
      • Research Site
• Chile
  • Santiago, Chile, 8420383
    • Research Site
  • Santiago, Chile, 7501126
    • Research Site
  • Santiago, Chile, 7640881
    • Research Site
• Czechia
  • Brno, Czechia, 638 00
    • Research Site
  • Ostrava-Trebovice, Czechia, 722 00
    • Research Site
  • Pardubice, Czechia, 530 02
    • Research Site
  • Praha 2, Czechia, 128 08
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  • Praha 2, Czechia, 128 50
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  • Uherske Hradiste, Czechia, 686 01
    • Research Site
  • Zlin, Czechia, 760 01
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• France
  • Lyon Cédex 3, France, 69437
    • Research Site
  • Poitiers, France, 86000
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 12462
    • Research Site
  • Athens, Greece, 11521
    • Research Site
  • Thessaloniki, Greece, 56429
    • Research Site
• Hungary
  • Budapest, Hungary, 1036
    • Research Site
  • Nyiregyhaza, Hungary, 4400
    • Research Site
  • Szolnok, Hungary, 5000
    • Research Site
  • Szombathely, Hungary, 9700
    • Research Site
  • Veszprem, Hungary, 8200
    • Research Site
• Latvia
  • Liepaja, Latvia, 3401
    • Research Site
  • Riga, Latvia, 1003
    • Research Site
  • Valmiera, Latvia, 4201
    • Research Site
• Mexico
  • Chihuahua, Mexico, 31000
    • Research Site
  • Baja California Norte
    • Mexicali, Baja California Norte, Mexico, 21100
      • Research Site
    • Mexicalli, Baja California Norte, Mexico, 21200
      • Research Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Research Site
    • Zapopan, Jalisco, Mexico, 45190
      • Research Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64020
      • Research Site
    • Monterrey, Nuevo León, Mexico, 64718
      • Research Site
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80000
      • Research Site
• Poland
  • Gdansk, Poland, 80-402
    • Research Site
  • Lodz, Poland, 90-436
    • Research Site
  • Warszawa, Poland, 01-817
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  • Wroclaw, Poland, 50-368
    • Research Site
  • Wroclaw, Poland, 51-318
    • Research Site
• Portugal
  • Lisboa, Portugal, 1050-034
    • Research Site
  • Lisboa, Portugal, 1649-034
    • Research Site
  • Ponte de Lima, Portugal, 4990-041
    • Research Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Research Site
  • San Juan, Puerto Rico, 00918
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454076
    • Research Site
  • Ekaterinburg, Russian Federation, 620102
    • Research Site
  • Kemerovo, Russian Federation, 650000
    • Research Site
  • Kursk, Russian Federation, 305007
    • Research Site
  • Moscow, Russian Federation, 115522
    • Research Site
  • Moscow, Russian Federation, 119992
    • Research Site
  • Novosibirsk, Russian Federation, 630005
    • Research Site
  • Orenburg, Russian Federation, 460018
    • Research Site
  • Petrozavodsk, Russian Federation, 185019
    • Research Site
  • Ryazan, Russian Federation, 390026
    • Research Site
  • Saratov, Russian Federation, 410053
    • Research Site
  • Smolensk, Russian Federation, 214025
    • Research Site
  • Vladimir, Russian Federation, 600023
    • Research Site
  • Yaroslavl, Russian Federation, 150003
    • Research Site
  • Yaroslavl, Russian Federation, 150062
    • Research Site
• South Africa
  • Western Cape
    • Panorama, Western Cape, South Africa, 7500
      • Research Site
    • Pinelands, Western Cape, South Africa, 7405
      • Research Site
    • Stellenbosch, Western Cape, South Africa, 7600
      • Research Site
• Spain
  • Andalucía
    • Cordoba, Andalucía, Spain, 14004
      • Research Site
  • Comunidad Valenciana
    • La Vila-Joiosa, Comunidad Valenciana, Spain, 03570
      • Research Site
  • Extremadura
    • Merida, Extremadura, Spain, 06800
      • Research Site
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Research Site
• United Kingdom
  • Bradford, United Kingdom, BD5 0NA
    • Research Site
  • Dudley, United Kingdom, DY1 2HQ
    • Research Site
  • Nottingham, United Kingdom, NG7 2UH
    • Research Site
• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35406
      • Research Site
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Research Site
    • Mesa, Arizona, United States, 85202
      • Research Site
    • Scottsdale, Arizona, United States, 85258
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
  • California
    • Escondido, California, United States, 92025
      • Research Site
    • Hemet, California, United States, 92543
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Mather, California, United States, 95655
      • Research Site
    • Palm Desert, California, United States, 92260
      • Research Site
    • San Francisco, California, United States, 94143
      • Research Site
    • Santa Monica, California, United States, 90404
      • Research Site
    • Thousand Oaks, California, United States, 91360
      • Research Site
    • Tustin, California, United States, 92780
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  • Florida
    • Aventura, Florida, United States, 33180
      • Research Site
    • Clearwater, Florida, United States, 33765
      • Research Site
    • Kissimmee, Florida, United States, 34741
      • Research Site
    • Ocoee, Florida, United States, 34761
      • Research Site
    • Tampa, Florida, United States, 33613
      • Research Site
    • Tampa, Florida, United States, 33609
      • Research Site
    • Zephyrhills, Florida, United States, 33542
      • Research Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Research Site
    • Springfield, Illinois, United States, 62703
      • Research Site
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Research Site
    • Paducah, Kentucky, United States, 42003
      • Research Site
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Research Site
    • Hagerstown, Maryland, United States, 21740
      • Research Site
    • Wheaton, Maryland, United States, 20902
      • Research Site
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Research Site
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Research Site
    • Lansing, Michigan, United States, 48917
      • Research Site
    • Saint Clair Shores, Michigan, United States, 48081
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
  • New Jersey
    • Clifton, New Jersey, United States, 07012
      • Research Site
    • Freehold, New Jersey, United States, 07728
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Research Site
    • Rochester, New York, United States, 14642
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Research Site
    • Charlotte, North Carolina, United States, 28204
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Research Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Research Site
    • San Antonio, Texas, United States, 78232
      • Research Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Research Site
    • Danville, Virginia, United States, 24541
      • Research Site
    • Roanoke, Virginia, United States, 24016
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methotrexate Monotherapy; Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.	Drug: Methotrexate; Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.; Drug: Placebo to Etanercept; Placebo to etanercept was administered by subcutaneous injection once a week.
Experimental: Etanercept Monotherapy; Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.	Drug: Etanercept; Etanercept was administered by subcutaneous injection once a week; Other Names: Enbrel; Drug: Placebo to Methotrexate; Placebo to methotrexate capsules taken orally once a week.
Experimental: Methotrexate + Etanercept; Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.	Drug: Methotrexate; Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.; Drug: Etanercept; Etanercept was administered by subcutaneous injection once a week; Other Names: Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24	A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 20% improvement in 68 tender joint count;; ≥ 20% improvement in 66 swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters:Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);Patient's global assessment of disease activity (measured on a 100 mm VAS);Physician's global assessment of disease activity (measured on a 100 mm VAS);Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);C-reactive protein concentration.	Baseline and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24	Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: Tender joint count (0-68) ≤ 1; Swollen joint count (0-66) ≤ 1; Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3%; Patient global assessment of joint pain VAS (0-100) ≤ 15; Patient global assessment of disease activity VAS (0-100) ≤ 20; HAQ-DI (0-3) ≤ 0.5; Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1	Week 24
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time	A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 20% improvement in 68 tender joint count;; ≥ 20% improvement in 66 swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters:Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);Patient's global assessment of disease activity (measured on a 100 mm VAS);Physician's global assessment of disease activity (measured on a 100 mm VAS);Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);C-reactive protein.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time	A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 50% improvement in 68 tender joint count;; ≥ 50% improvement in 66 swollen joint count; and; ≥ 50% improvement in at least 3 of the 5 following parameters:Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);Patient's global assessment of disease activity (measured on a 100 mm VAS);Physician's global assessment of disease activity (measured on a 100 mm VAS);Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);C-reactive protein.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time	A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: ≥ 70% improvement in 68 tender joint count;; ≥ 70% improvement in 66 swollen joint count; and; ≥ 70% improvement in at least 3 of the 5 following parameters:Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);Patient's global assessment of disease activity (measured on a 100 mm VAS);Physician's global assessment of disease activity (measured on a 100 mm VAS);Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);C-reactive protein.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Tender Joint Count Over Time	The tender joint count is an assessment of the pain and/or tenderness of 68 joints using a 0 to 1 point scale (0 = none, 1 = present). The total tender joint count is calculated by summing the number of joints with present tenderness.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Swollen Joint Count Over Time	The swollen joint count is an assessment of the swelling of 66 joints using a 0 to 1 point scale (0 = none, 1 = present). The total swollen joint count is calculated by summing the number of joints with present swelling.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Physician Global Assessment of Disease Activity Over Time	A global assessment of the participant's arthritis assessed by the physician on a 100 mm visual analog scale (VAS) where 0 mm = No activity at all and 100 mm = Worst activity imaginable.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Patient Global Assessment of Disease Activity Over Time	A global assessment of the participant's arthritis, assessed by the participant on a 100 mm VAS where 0 mm = No arthritis activity at all and 100 mm = Worst arthritis activity imaginable.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Patient Global Assessment of Joint Pain Over Time	A global assessment of the severity of the participant's joint pain, assessed by the participant on a 100 mm VAS where 0 mm = No pain at all and 100 mm = Worst pain imaginable.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time	The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in C-reactive Protein Concentration Over Time	C-reactive protein (CRP) is a specific measure of inflammatory activity.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time	Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: Tender joint count (0-68) ≤ 1; Swollen joint count (0-66) ≤ 1; Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3%; Patient global assessment of joint pain VAS (0-100) ≤ 15; Patient global assessment of disease activity VAS (0-100) ≤ 20; HAQ-DI (0-3) ≤ 0.5; Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1	Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time	PASDAS is a measure of disease activity derived from the following variables: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS); 68 tender joint count; 66 swollen joint count; Short Form-36 Questionnaire (SF-36) physical component summary (general health status on a scale from 0-100); Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20); Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6); CRP level (mg/L) The composite score is a weighted index where higher scores indicate more severe disease.	Baseline and weeks 12, 24, 36, and 48
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time	The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the following items: 28 tender joint count,; 28 swollen joint count,; Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest;; Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time	The Simplified Disease Activity Index (SDAI) is a composite index that is calculated as the sum of the following items: 28 tender joint count,; 28 swollen joint count,; Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest;; Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.; CRP The SDAI score ranges from 0 to 86 with higher scores representing worse disease.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time	The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count; 28 swollen joint count; C-reactive protein (CRP); Patient's global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.	Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24	The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring in 8 functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.	Baseline and week 24
Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24	The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains. Two summary component scores are calculated: mental component summary score (MCS) and physical component summary score (PCS). The MCS consists of social functioning, vitality, mental health, and role-emotional scales and the PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.	Baseline and week 24
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24	The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features: pitting (scores 0-3, depending on the number of pits); nail plate crumbling (scores 0-3, depending on the % of nail involvement); onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement); leukonychia (0 = absent, 1 = present); red spots in lunula (0 = absent, 1 = present); nail bed hyperkeratosis (0 = absent, 1 = present); splinter hemorrhages (0 = absent, 1 = present) In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, the fingernail with the highest mNAPSI score). This fingernail was followed for the remainder of the study. mNAPSI scores range from 0-13 where higher scores represent worse nail disease.	Baseline and week 24
Percentage of Participants With Clear mNAPSI at Week 24	The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features: pitting (scores 0-3, depending on the number of pits); nail plate crumbling (scores 0-3, depending on the % of nail involvement); onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement); leukonychia (0 = absent, 1 = present); red spots in lunula (0 = absent, 1 = present); nail bed hyperkeratosis (0 = absent, 1 = present); splinter hemorrhages (0 = absent, 1 = present) In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, the fingernail with the highest mNAPSI score). This fingernail was followed for the remainder of the study. mNAPSI scores range from 0-13 where higher scores represent worse nail disease. Clear mNAPSI is defined as a score = 0.	Baseline and week 24
Change From Baseline in Leeds Dactylitis Index (LDI) at Week 24	The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst]. The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.	Baseline and week 24
Percentage of Participants With Clear LDI at Week 24	The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst]. The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. Clear LDI is defined as a score = 0.	Baseline and week 24
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24	The SPARCC enthesitis index assesses enthesitis at 18 sites for palpitation with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity). Tenderness at each site is quantified on a dichotomous basis (0 = non-tender, 1 = tender). Entheses assessed are medial epicondyle (left and right), lateral epicondyle (left and right), supraspinatus insertion into greater tuberosity of humerus (left and right), greater trochanter (left and right), quadriceps insertion into superior border of patella (left and right), patellar ligament insertion into inferior pole of patella or tibial tubercle (left and right), Achilles tendon insertion into calcaneum (left and right), plantar fascia insertion into calcaneum (left and right). A higher count represents greater enthesitis burden.	Baseline and week 24
Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24	The SPARCC enthesitis index assesses enthesitis at 18 sites for palpitation with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity). Tenderness at each site is quantified on a dichotomous basis (0 = non-tender, 1 = tender). Entheses assessed are medial epicondyle (left and right), lateral epicondyle (left and right), supraspinatus insertion into greater tuberosity of humerus (left and right), greater trochanter (left and right), quadriceps insertion into superior border of patella (left and right), patellar ligament insertion into inferior pole of patella or tibial tubercle (left and right), Achilles tendon insertion into calcaneum (left and right), plantar fascia insertion into calcaneum (left and right). A higher count represents greater enthesitis burden. Clear SPARCC enthesitis is defined as a score = 0.	Baseline and week 24
Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24	The physician's assessment of the percentage of the participant's total body surface area involved with psoriasis. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline * 100	Baseline and week 24
Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups	The physician's assessment of the percentage of the participant's total body surface area involved with psoriasis. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline * 100	Baseline and week 24
Static Physician Global Assessment (sPGA) at Week 24	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Week 24
Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Week 24
Mean Static Physician Global Assessment (sPGA) Score at Week 24	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Week 24
Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Week 24
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Week 24
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Week 24
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Baseline and week 24
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Baseline and week 24
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Baseline and week 24
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups	The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).	Baseline and week 24

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Mease PJ, Gladman DD, Samad AS, Coates LC, Liu LXH, Aras GA, Collier DH, Chung JB. Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA). RMD Open. 2018 Feb 3;4(1):e000606. doi: 10.1136/rmdopen-2017-000606. eCollection 2018.
• Mease PJ, Gladman DD, Collier DH, Ritchlin CT, Helliwell PS, Liu L, Kricorian G, Chung JB. Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial. Arthritis Rheumatol. 2019 Jul;71(7):1112-1124. doi: 10.1002/art.40851. Epub 2019 May 28.
• Strand V, Mease PJ, Maksabedian Hernandez EJ, Stolshek BS, Liu LXH, Collier DH, Kricorian G, Merola JF. Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination. RMD Open. 2021 Jan;7(1):e001484. doi: 10.1136/rmdopen-2020-001484.
• Coates LC, Merola JF, Mease PJ, Ogdie A, Gladman DD, Strand V, van Mens LJJ, Liu L, Yen PK, Collier DH, Kricorian G, Chung JB, Helliwell PS. Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis. Rheumatology (Oxford). 2021 Mar 2;60(3):1137-1147. doi: 10.1093/rheumatology/keaa271.
• Helliwell PS, Mease PJ, Kavanaugh A, Coates LC, Ogdie A, Deodhar A, Strand V, Kricorian G, Liu LXH, Collier D, Gladman DD. Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: comparison of treatment effects in the SEAM-PsA trial. RMD Open. 2022 Jul;8(2):e002366. doi: 10.1136/rmdopen-2022-002366.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2015
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Methotrexate; Psoriatic Arthritis; Enbrel; Etanercept; Arthritis, Psoriasis; Minimal Disease Activity
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Etanercept; Methotrexate
• Other Study ID Numbers: 20130207; 2014-004869-24 (EudraCT Number)