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: Current controlled trials in cardiovascular medicine 2015-04, Vol.16 (1), p.178-178, Article 178
• Main Authors: Møller-Bisgaard, Signe, Hørslev-Petersen, Kim, Ejbjerg, Bo Jannik, Boesen, Mikael, Hetland, Merete Lund, Christensen, Robin, Møller, Jakob, Krogh, Niels Steen, Stengaard-Pedersen, Kristian, Østergaard, Mikkel
• Format: Article
• Language: English
• Subjects: Algorithms; Analysis; Antirheumatic agents; Antirheumatic Agents - therapeutic use; Arthritis; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Arthritis, Rheumatoid - pathology; Bone marrow; Bone Marrow - drug effects; Bone Marrow - pathology; Care and treatment; Clinical Protocols; Clinical trials; Contraindications; Denmark; Disability; Disease Progression; Drug dosages; Drug therapy; Edema - pathology; Health aspects; Humans; Intervention; Joints - drug effects; Joints - pathology; Laboratories; Magnetic Resonance Imaging; Medical prognosis; Patients; Pharmaceutical industry; Predictive Value of Tests; Remission (Medicine); Remission Induction; Research Design; Rheumatoid arthritis; Rheumatoid factor; Rheumatology; Severity of Illness Index; Study Protocol; Substance abuse treatment; Time Factors; Treatment Outcome
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-015-0693-2

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