Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA)

Objective To evaluate the efficacy of etanerceptand methotrexateas monotherapies and as combination therapyin subjects with active psoriatic arthritis(PsA). Methods The Study of Etanerceptand Methotrexatein 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 etanerceptmonotherapy, methotrexatemonotherapy 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 etanerceptwith and without background methotrexateand methotrexatealone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA.