Clinical trial NCT02376790: Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
Official title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Arthritis, Psoriasis
Etanercept
Enbrel
Methotrexate
Minimal Disease Activity
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Tender Joint Count Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Swollen Joint Count Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Physician Global Assessment of Disease Activity Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Patient Global Assessment of Disease Activity Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Patient Global Assessment of Joint Pain Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in C-reactive Protein Concentration Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time
timeFrame: Baseline and weeks 12, 24, 36, and 48
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time
timeFrame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24
timeFrame: Baseline and week 24
measure: Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24
timeFrame: Baseline and week 24
measure: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With Clear mNAPSI at Week 24
timeFrame: Baseline and week 24
measure: Change From Baseline in Leeds Dactylitis Index (LDI) at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With Clear LDI at Week 24
timeFrame: Baseline and week 24
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24
timeFrame: Baseline and week 24
measure: Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24
timeFrame: Baseline and week 24
measure: Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups
timeFrame: Baseline and week 24
measure: Static Physician Global Assessment (sPGA) at Week 24
timeFrame: Week 24
measure: Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups
timeFrame: Week 24
measure: Mean Static Physician Global Assessment (sPGA) Score at Week 24
timeFrame: Week 24
measure: Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups
timeFrame: Week 24
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups
timeFrame: Week 24
measure: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups
timeFrame: Baseline and week 24
measure: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Escondido
country: United States
facility: Research Site
state: California
city: Hemet
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mather
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Thousand Oaks
country: United States
facility: Research Site
state: California
city: Tustin
country: United States
facility: Research Site
state: California
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Kissimmee
country: United States
facility: Research Site
state: Florida
city: Ocoee
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Zephyrhills
country: United States
facility: Research Site
state: Florida
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Bowling Green
country: United States
facility: Research Site
state: Kentucky
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Saint Clair Shores
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
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state: Minnesota
city: Las Vegas
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state: Nevada
city: Lebanon
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state: New Hampshire
city: Clifton
country: United States
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state: New Jersey
city: Freehold
country: United States
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state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
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state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Cleveland
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Duncansville
country: United States
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state: Pennsylvania
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Danville
country: United States
facility: Research Site
state: Virginia
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Rouse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Ostrava-Trebovice
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Lyon Cédex 3
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Mexicali
country: Mexico
facility: Research Site
state: Baja California Norte
city: Mexicalli
country: Mexico
facility: Research Site
state: Baja California Norte
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Culiacan
country: Mexico
facility: Research Site
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Ponte de Lima
country: Portugal
facility: Research Site
city: Ponce
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Panorama
country: South Africa
facility: Research Site
state: Western Cape
city: Pinelands
country: South Africa
facility: Research Site
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Research Site
state: Western Cape
city: Cordoba
country: Spain
facility: Research Site
state: Andalucía
city: La Vila-Joiosa
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Merida
country: Spain
facility: Research Site
state: Extremadura
city: A Coruña
country: Spain
facility: Research Site
state: Galicia
city: Bradford
country: United Kingdom
facility: Research Site
city: Dudley
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.