title: A prospective, single-centre, randomised study evaluating the clinical, imaging and immunological depth of remission achieved by very early versus delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA).
abstract: BACKGROUND
  Rheumatoid arthritis (RA) is a chronic inflammatory arthritis, with significant impact on quality of life and functional status. Whilst biologic disease modifying anti-rheumatic drugs (bDMARD) such as tumour necrosis factor-inhibitor (TNFi) agents have revolutionised outcomes in RA, early diagnosis with immediate conventional therapy, titrated in a treat to target approach is also associated with high remission rates. The main aim of the VEDERA study (Very Early versus Delayed Etanercept in Rheumatoid Arthritis) is to assess the depth of remission, sustainability of remission and immunological normalisation induced by very early TNFi with etanercept (ETN) or standard of care +/- delayed ETN.
  
  
  METHODS
  VEDERA is a pragmatic, phase IV single-centre open-label randomised superiority trial of 120 patients with early, treatment-naive RA. Patients will be randomised 1:1 to first-line ETN and methotrexate (MTX) or MTX with additional synthetic disease modifying anti-rheumatic drugs (sDMARDs) according to a treat to target (TT) protocol with further step up to ETN and MTX after 24 weeks if remission is not achieved. Participants will have regular disease activity assessments and imaging evaluation including musculoskeletal ultrasound and MRI. The main objective of this study is to assess the proportion of patients with early RA that achieve clinical remission at 48 weeks, following either treatment strategy. In addition, the participants are invited to take part in a cardio-vascular sub-study (Coronary Artery Disease in RA, CADERA), which aims to identify the incidence of cardiovascular abnormalities in early RA.
  
  
  CONCLUSIONS
  The hypothesis underlining this study is that very early treatment with first-line ETN increases the proportion of patients with rheumatoid arthritis achieving clinical remission, in comparison to conventional therapy.
  
  
  BACKGROUND
  NCT02433184 , 23/04/2015.
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.|NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Raluca B
authors: RB
authors: Dumitru
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.|NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Sarah
authors: S
authors: Horton
authors: University of Manchester Centre for Imaging Sciences, Manchester, UK.
authors: Richard
authors: R
authors: Hodgson
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.|NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Richard J
authors: RJ
authors: Wakefield
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.|NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Elizabeth M A
authors: EMA
authors: Hensor
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.|NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Paul
authors: P
authors: Emery
authors: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. m.buch@leeds.ac.uk.|NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK. m.buch@leeds.ac.uk.
authors: Maya H
authors: MH
authors: Buch
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology*; D004334:Drug Administration Schedule; D000068800:Etanercept / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept