title: Impact of a magnetic resonance imaging-guided treat-to-target strategy on disease activity and progression in patients with rheumatoid arthritis (the IMAGINE-RA trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Rheumatoid arthritis (RA) is a chronic, progressive joint disease, which frequently leads to irreversible joint deformity and severe functional impairment. Although patients are treated according to existing guidelines and reach clinical remission, erosive progression still occurs. This demonstrates that additional methods for prognostication and monitoring of the disease activity are needed. Bone marrow edema (BME) detected by magnetic resonance imaging (MRI) has proved to be an independent predictor of subsequent radiographic progression. Guiding the treatment based on the presence/absence of BME may therefore be clinically beneficial. We present the design of a randomized controlled trial (RCT) aiming to evaluate whether an MRI-guided treatment strategy compared to a conventional treatment strategy in anti-CCP-positive erosive RA is better to prevent progression of erosive joint damage and increase the remission rate in patients with low disease activity or clinical remission.
  
  
  METHODS
  The study is a non-blinded, multicenter, 2-year RCT with a parallel group design. Two hundred anti-CCP-positive, erosive RA patients characterized by low disease activity or remission, no clinically swollen joints and treatment with synthetic disease-modifying antirheumatic drugs (DMARDs) will be included. Patients will be randomized to either a treatment strategy based on conventional laboratory and clinical examinations (control group) or a treatment strategy based on conventional laboratory and clinical examinations as well as MRI (intervention group). Treatment is intensified according to a predefined treatment algorithm in case of inflammation defined as a disease activity score (DAS28) >3.2 and at least one clinically swollen joint (control and intervention groups) and/or MRI-detected BME (intervention group only). The primary outcome measures are DAS28 remission (DAS28 < 2.6) and radiographic progression (Sharp/vdHeijde score).
  
  
  CONCLUSIONS
  The perspectives, strengths and weaknesses of this study are discussed. This study has been approved by The Regional Scientific Ethical Committees for Southern Denmark, S-20110109. Dissemination will occur through presentations and publication in international peer-reviewed journals.
  
  
  BACKGROUND
  The study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012).
authors.affiliation: Department of Rheumatology, Copenhagen University Hospital, Slagelse, Denmark. s.mb@dadlnet.dk.|DANBIO registry and Copenhagen Centre for Arthritis Research, Centre for Rheumatology and Spine Diseases, Copenhagen University Hospital, Glostrup, Denmark. s.mb@dadlnet.dk.
authors.forename: Signe
authors.initials: S
authors.lastname: Møller-Bisgaard
authors.affiliation: King Christian 10th Hospital for Rheumatic Diseases, Graasten and Institute of Regional Health research, University of Southern Denmark, Odense, Denmark. khorslevpetersen@gigtforeningen.dk.
authors.forename: Kim
authors.initials: K
authors.lastname: Hørslev-Petersen
authors.affiliation: Department of Rheumatology, Copenhagen University Hospital, Slagelse, Denmark. bjej@regionsjaelland.dk.
authors.forename: Bo Jannik
authors.initials: BJ
authors.lastname: Ejbjerg
authors.affiliation: Department of Radiology and the imaging unit, The Parker institute, Copenhagen University Hospital, Bispebjerg-Frederiksberg, Copenhagen F, Denmark. mikael.boesen@dadlnet.dk.
authors.forename: Mikael
authors.initials: M
authors.lastname: Boesen
authors.affiliation: DANBIO registry and Copenhagen Centre for Arthritis Research, Centre for Rheumatology and Spine Diseases, Copenhagen University Hospital, Glostrup, Denmark. merete.hetland@dadlnet.dk.
authors.forename: Merete Lund
authors.initials: ML
authors.lastname: Hetland
authors.affiliation: Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen F, Denmark. robin.christensen@regionh.dk.
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.affiliation: Department of radiology, Copenhagen University Hospital, Herlev, Denmark. jakob.moeller@regionh.dk.
authors.forename: Jakob
authors.initials: J
authors.lastname: Møller
authors.affiliation: ZiteLab ApS, Copenhagen, Denmark. nielssteenkrogh@zitelab.dk.
authors.forename: Niels Steen
authors.initials: NS
authors.lastname: Krogh
authors.affiliation: Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark. stengaard@clin.au.dk.
authors.forename: Kristian
authors.initials: K
authors.lastname: Stengaard-Pedersen
authors.affiliation: DANBIO registry and Copenhagen Centre for Arthritis Research, Centre for Rheumatology and Spine Diseases, Copenhagen University Hospital, Glostrup, Denmark. mo@dadlnet.dk.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Østergaard
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology; D001853:Bone Marrow / Q000187:drug effects / Q000473:pathology; D002985:Clinical Protocols; D003718:Denmark; D018450:Disease Progression; D004487:Edema / Q000473:pathology*; D006801:Humans; D007596:Joints / Q000187:drug effects / Q000473:pathology; D008279:Magnetic Resonance Imaging; D011237:Predictive Value of Tests; D012074:Remission Induction; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents