A Phase 3 Study with Etanercept & Methotrexate in Psoriatic Arthritis
Research type
Research Study
Full title
A Multicenter Double-blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
IRAS ID
195518
Contact name
Diane Beauvais
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2014-004869-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 0 days
Research 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 participants with psoriatic arthritis.
To do this, etanercept alone will be compared to methotrexate alone and to a combination of etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an individual participant.
Participants will be randomized into 1 of 3 groups. Participants will have a 1 in 3 chance of receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the subject nor the study doctor can choose the group to which the participant will be randomized into. Participants will take one study medication by injection under their skin and a second medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the participant and determines that their condition has not improved, the participant may qualify to receive etanercept plus methotrexate
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0128
Date of REC Opinion
4 May 2016
REC opinion
Further Information Favourable Opinion