GOLMePsA
Research type
Research Study
Full title
An investigator‐initiated double‐blind, parallel‐group randomised controlled trial of GOLimumab and Methotrexate versus Methotrexate in very early PsA using clinical and whole body MRI outcomes: the GOLMePsA study.
IRAS ID
143399
Contact name
Helena Marzo-Ortega
Contact email
Sponsor organisation
The Leeds Teaching Hospitals NHS Trust
Eudract number
2013-004122-28
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a pilot study to assess the feasibility of conducting a clinical trial of the efficacy of a treatment strategy incorporating a combination of golimumab and methotrexate, in early Psoriatic Arthritis, compared to methotrexate alone using WB-MRI. Efficacy of treatment will be assessed against the number of inflammatory lesions that are present on WB-MRI at 24 weeks post randomisation. It is conceived as a pilot study given the lack of data on WB-MRI in PsA. As such, the sample size has been estimated to account for recruitment rate, the attrition rate and the number of active lesions following treatment (the primary outcome).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0124
Date of REC Opinion
23 Apr 2014
REC opinion
Further Information Favourable Opinion