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
2 other identifiers
interventional
851
18 countries
138
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2015
Typical duration for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedStudy Start
First participant enrolled
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2018
CompletedResults Posted
Study results publicly available
February 22, 2019
CompletedSeptember 21, 2022
September 1, 2022
2.9 years
January 28, 2015
January 8, 2019
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (36)
Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24
Week 24
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
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
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
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Change From Baseline in Tender Joint Count Over Time
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
- +31 more secondary outcomes
Study Arms (3)
Methotrexate Monotherapy
ACTIVE COMPARATORParticipants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
Etanercept Monotherapy
EXPERIMENTALParticipants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
Methotrexate + Etanercept
EXPERIMENTALParticipants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.
Interventions
Etanercept was administered by subcutaneous injection once a week
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.
Placebo to etanercept was administered by subcutaneous injection once a week.
Placebo to methotrexate capsules taken orally once a week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (138)
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Tuscaloosa, Alabama, 35406, United States
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Glendale, Arizona, 85306, United States
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Mesa, Arizona, 85202, United States
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Scottsdale, Arizona, 85258, United States
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Little Rock, Arkansas, 72205, United States
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Escondido, California, 92025, United States
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Hemet, California, 92543, United States
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Los Angeles, California, 90095, United States
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Mather, California, 95655, United States
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Palm Desert, California, 92260, United States
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San Francisco, California, 94143, United States
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Santa Monica, California, 90404, United States
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Thousand Oaks, California, 91360, United States
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Tustin, California, 92780, United States
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Aventura, Florida, 33180, United States
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Clearwater, Florida, 33765, United States
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Kissimmee, Florida, 34741, United States
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Ocoee, Florida, 34761, United States
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Tampa, Florida, 33609, United States
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Tampa, Florida, 33613, United States
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Zephyrhills, Florida, 33542, United States
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Meridian, Idaho, 83642, United States
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Chicago, Illinois, 60611, United States
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Springfield, Illinois, 62703, United States
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Bowling Green, Kentucky, 42101, United States
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Paducah, Kentucky, 42003, United States
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Frederick, Maryland, 21702, United States
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Hagerstown, Maryland, 21740, United States
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Wheaton, Maryland, 20902, United States
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Worcester, Massachusetts, 01605, United States
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Lansing, Michigan, 48910, United States
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Lansing, Michigan, 48917, United States
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Saint Clair Shores, Michigan, 48081, United States
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Rochester, Minnesota, 55905, United States
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Las Vegas, Nevada, 89128, United States
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Lebanon, New Hampshire, 03756, United States
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Clifton, New Jersey, 07012, United States
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Freehold, New Jersey, 07728, United States
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Albuquerque, New Mexico, 87102, United States
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New York, New York, 10016, United States
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Rochester, New York, 14642, United States
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Asheville, North Carolina, 28803, United States
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Charlotte, North Carolina, 28204, United States
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Cleveland, Ohio, 44109, United States
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Oklahoma City, Oklahoma, 73103, United States
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Duncansville, Pennsylvania, 16635, United States
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Wyomissing, Pennsylvania, 19610, United States
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Charleston, South Carolina, 29406, United States
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Rapid City, South Dakota, 57701, United States
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Dallas, Texas, 75231, United States
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San Antonio, Texas, 78232, United States
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Chesapeake, Virginia, 23320, United States
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Danville, Virginia, 24541, United States
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Roanoke, Virginia, 24016, United States
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Seattle, Washington, 98104, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1015ABO, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
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Buenos Aires, 1425, Argentina
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Burgas, 8000, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1612, Bulgaria
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Sofia, 1784, Bulgaria
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Surrey, British Columbia, V3R 6A7, Canada
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Winnipeg, Manitoba, R3N 0K6, Canada
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London, Ontario, N6A 3H7, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Québec, Quebec, G1V 3M7, Canada
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Trois-Rivières, Quebec, G8Z 1Y2, Canada
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Saskatoon, Saskatchewan, S7K 3H3, Canada
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Santiago, 7501126, Chile
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Santiago, 7640881, Chile
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Santiago, 8420383, Chile
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Brno, 638 00, Czechia
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Ostrava-Trebovice, 722 00, Czechia
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Pardubice, 530 02, Czechia
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Prague, 128 08, Czechia
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Prague, 128 50, Czechia
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Uherské Hradiště, 686 01, Czechia
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Zlín, 760 01, Czechia
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Lyon Cédex 3, 69437, France
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Poitiers, 86000, France
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Athens, 11521, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Thessaloniki, 56429, Greece
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Budapest, 1036, Hungary
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Nyíregyháza, 4400, Hungary
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Szolnok, 5000, Hungary
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Szombathely, 9700, Hungary
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Veszprém, 8200, Hungary
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Liepāja, 3401, Latvia
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Riga, 1003, Latvia
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Valmiera, 4201, Latvia
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Mexicali, Baja California Norte, 21100, Mexico
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Mexicalli, Baja California Norte, 21200, Mexico
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Guadalajara, Jalisco, 44650, Mexico
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Zapopan, Jalisco, 45190, Mexico
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Monterrey, Nuevo León, 64020, Mexico
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Monterrey, Nuevo León, 64718, Mexico
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Culiacán, Sinaloa, 80000, Mexico
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Chihuahua City, 31000, Mexico
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Gdansk, 80-402, Poland
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Lodz, 90-436, Poland
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Warsaw, 01-817, Poland
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Wroclaw, 50-368, Poland
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Wroclaw, 51-318, Poland
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Lisbon, 1050-034, Portugal
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Lisbon, 1649-034, Portugal
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Ponte de Lima, 4990-041, Portugal
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Ponce, 00716, Puerto Rico
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San Juan, 00918, Puerto Rico
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Chelyabinsk, 454076, Russia
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Kemerovo, 650000, Russia
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Kursk, 305007, Russia
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Moscow, 115522, Russia
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Moscow, 119992, Russia
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Novosibirsk, 630005, Russia
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Orenburg, 460018, Russia
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Petrozavodsk, 185019, Russia
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Ryazan, 390026, Russia
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Saratov, 410053, Russia
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Smolensk, 214025, Russia
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Vladimir, 600023, Russia
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Yaroslavl, 150003, Russia
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Yaroslavl, 150062, Russia
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Yekaterinburg, 620102, Russia
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Panorama, Western Cape, 7500, South Africa
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Pinelands, Western Cape, 7405, South Africa
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Stellenbosch, Western Cape, 7600, South Africa
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Córdoba, Andalusia, 14004, Spain
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Mérida, Extremadura, 06800, Spain
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A Coruña, Galicia, 15006, Spain
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Villajoyosa, Valencia, 03570, Spain
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Bradford, BD5 0NA, United Kingdom
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Dudley, DY1 2HQ, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
Related Publications (5)
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.
PMID: 29531787BACKGROUNDMease 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.
PMID: 30747501BACKGROUNDStrand 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.
PMID: 33452180BACKGROUNDCoates 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.
PMID: 32864685BACKGROUNDHelliwell 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.
PMID: 35863864BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2015
First Posted
March 3, 2015
Study Start
March 3, 2015
Primary Completion
January 9, 2018
Study Completion
July 6, 2018
Last Updated
September 21, 2022
Results First Posted
February 22, 2019
Record last verified: 2022-09