EMPIRE 2006.

Trial name or title	EMPIRE (Etanercept and Methotrexate in Patients to Induce Remission in Early arthritis)
Methods	Multicentre, double‐blind, placebo‐controlled RCT
Participants	Inclusion: aged 18‐80 years; articular synovitis within 3 months of diagnosis; either rheumatoid factor antibody positive or anti‐cyclic citrullinated peptide positive; not pregnant; negative TB screening test Exclusion: previous treatment with DMARDs, etanercept or TNF drugs; HIV; significant concurrent medical diseases; cancer or history of cancer; chronic infection of upper respiratory tract; ongoing or active infection; liver function abnormality; renal disease; leukopenia; thrombocytopenia, etc. (large list of exclusions)
Interventions	Etanercept + MTX vs. placebo + MTX
Outcomes	Primary: proportion in clinical remission at 12 months (defined as absence of symptoms and signs of inflammatory arthritis: i.e. SJC = 0; TJC = 0) Secondary: number of participants in clinical remission at 18 months (see above for definition of remission); disease activity measures (VAS; EMS, TJC, SJC, CRP, ESR); functional, work and quality of life assessments (HAQ; WIS, WDA, EuroQol; SF‐36); proportion of participants achieving 26 weeks of remission; DAS28; radiographic change
Starting date	October 2006
Contact information	A.Keenan@Leeds.ac.uk
Notes	Funded by Wyeth