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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…

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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
Published in
Trials, April 2015
DOI 10.1186/s13063-015-0693-2
Pubmed ID
Authors

Signe Møller-Bisgaard, Kim Hørslev-Petersen, Bo Jannik Ejbjerg, Mikael Boesen, Merete Lund Hetland, Robin Christensen, Jakob Møller, Niels Steen Krogh, Kristian Stengaard-Pedersen, Mikkel Østergaard

Abstract

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. 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). 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. The study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012).

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Geographical breakdown

Country Count As %
Unknown 65 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 10 15%
Student > Master 10 15%
Student > Bachelor 5 8%
Researcher 5 8%
Student > Doctoral Student 4 6%
Other 12 18%
Unknown 19 29%
Readers by discipline Count As %
Medicine and Dentistry 28 43%
Nursing and Health Professions 4 6%
Pharmacology, Toxicology and Pharmaceutical Science 4 6%
Agricultural and Biological Sciences 2 3%
Economics, Econometrics and Finance 2 3%
Other 5 8%
Unknown 20 31%