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Original article
Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA)
  1. Philip J Mease1,
  2. Dafna D Gladman2,
  3. Ahmed S Samad3,
  4. Laura C Coates4,
  5. Lyrica X H Liu5,
  6. Girish A Aras5,
  7. David H Collier3 and
  8. James B Chung3
  1. 1 Rheumatology Clinical Research Division, Swedish Medical Center and Division of Rheumatology, University of Washington, Seattle, Washington, USA
  2. 2 Department of Medicine, University of Toronto, Toronto, Ontario, Canada
  3. 3 US Medical Organization, Amgen Inc., Thousand Oaks, CA, USA
  4. 4 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  5. 5 Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA
  1. Correspondence to Professor Philip J Mease; pmease{at}philipmease.com

Abstract

Objective To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA).

Methods The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) is an ongoing, global, double-blind, 48-week, randomised, controlled study. Subjects are randomised (1:1:1) to etanercept monotherapy, methotrexate monotherapy or etanercept-methotrexate combination therapy. Endpoints include rates of ACR20 response and Minimal Disease Activity, measures to characterise extra-articular manifestations (dactylitis, enthesitis, nail disease) and safety.

Conclusion SEAM-PsA will characterise the effects of etanercept with and without background methotrexate and methotrexate alone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA.

  • psoriatic arthritis
  • anti-TNF
  • methotrexate

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Footnotes

  • Contributors PJM, ASS, DHC and JBC contributed to the conception and design of the study, analysis and interpretation of data, and revision of the manuscript. DDG, LCC, LXHL and GAA contributed to the analysis and interpretation of data and revision of the manuscript. All authors approved the final draft of the manuscript for publication.

  • Funding This study was sponsored by Amgen.

  • Competing interests PJM has received research grants, served as a consultant, and/or participated as a speaker for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen Global Services, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sun Pharma, UCB, and Zynerba Pharmaceuticals. DDG has received research funding from and/or been a consultant to AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen Global Services, Novartis, Pfizer, and UCB. ASS, LXHL, GAA, DHC and JBC are employees and shareholders of Amgen. LCC has received research funding from and/or been a consultant for AbbVie, Amgen, Celgene, Janssen Global Services, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sun Pharma, and UCB.

  • Ethics approval Institutional Review Board approval is obtained from each study site.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The study is ongoing and is not available.

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