Abstract
BackgroundRheumatoid 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/designThe 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).DiscussionThe 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 registrationThe study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012)Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0693-2) contains supplementary material, which is available to authorized users.
Highlights
Rheumatoid arthritis (RA) is a chronic, progressive joint disease, which frequently leads to irreversible joint deformity and severe functional impairment
Patients typically experience joint pain, disability and loss of quality of life, and they are at risk of developing progressive joint damage, which eventually leads to irreversible joint deformity and severe functional impairment [2]
The aim of the present study is in an randomized controlled trial (RCT) to evaluate whether an imaging-based treat-to-target treatment strategy using magnetic resonance imaging (MRI) and Disease activity score (DAS) 28 (Disease Activity Score involving 28 joints) can prevent progression of erosive joint damage and increase the remission rate in patients with RA compared to a treat-to-target treatment strategy guided only by DAS 28
Summary
Rheumatoid arthritis (RA) is a chronic, progressive joint disease, which frequently leads to irreversible joint deformity and severe functional impairment. Other known prognostic factors of radiographic damage are existing radiographic damage, shared epitope alleles, rheumatoid factor (RF) and/or anti-citrullinated peptide (anti-CCP) antibody positivity and biochemical signs of inflammation [increased erythrocyte sedimentation rate (ESR) and Creactive protein (CRP)] at disease onset [7]. Even though these prognostic factors are all associated with poor radiographic outcome on a group level, at the individual patient level they cannot distinguish which patients will progress or not. MRI bone marrow edema, which reflects inflammatory infiltrates in the bone marrow (osteitis) [8,9], has proved to be a strong independent predictor of radiographic progression in patients with early RA [10,11,12] and may have significant prognostic value at an individual level
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