RT Journal Article
SR Electronic
T1 Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA)
JF RMD Open
JO RMD Open
FD EULAR
SP e000606
DO 10.1136/rmdopen-2017-000606
VO 4
IS 1
A1 Philip J Mease
A1 Dafna D Gladman
A1 Ahmed S Samad
A1 Laura C Coates
A1 Lyrica X H Liu
A1 Girish A Aras
A1 David H Collier
A1 James B Chung
YR 2018
UL http://rmdopen.bmj.com/content/4/1/e000606.abstract
AB 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.