TY - JOUR

T1 - 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)

T2 - study protocol for a randomized controlled trial

AU - Møller-Bisgaard, Signe

AU - Hørslev-Petersen, Kim

AU - Ejbjerg, Bo Jannik

AU - Boesen, Mikael

AU - Hetland, Merete Lund

AU - Christensen, Robin

AU - Møller, Jakob

AU - Krogh, Niels Steen

AU - Stengaard-Pedersen, Kristian

AU - Østergaard, Mikkel

PY - 2015

Y1 - 2015

N2 - 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/DESIGN: 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).DISCUSSION: 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.TRIAL REGISTRATION: The study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012).

AB - 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/DESIGN: 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).DISCUSSION: 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.TRIAL REGISTRATION: The study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012).

KW - Antirheumatic Agents

KW - Arthritis, Rheumatoid

KW - Bone Marrow

KW - Clinical Protocols

KW - Denmark

KW - Disease Progression

KW - Edema

KW - Humans

KW - Joints

KW - Magnetic Resonance Imaging

KW - Predictive Value of Tests

KW - Remission Induction

KW - Research Design

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s13063-015-0693-2

DO - 10.1186/s13063-015-0693-2

M3 - Journal article

C2 - 25896862

VL - 16

SP - 1

EP - 11

JO - Trials

JF - Trials

SN - 1745-6215

IS - 178

ER -