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.

Copyright © Author(s) (or their employer(s)) 2015.
Trials. 2015 Apr;7(178)_suppl doi: 10.1186/s13063-015-0693-2
Trial registration: http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012)

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/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.

Imaging in Rheumatoid Arthritis: The Role of Magnetic Resonance Imaging and Computed Tomography.

Abstract

In suspected and diagnosed rheumatoid arthritis (RA), magnetic resonance imaging (MRI) allows detection of all relevant pathologies, such as synovitis, tenosynovitis, bone marrow edema (osteitis), bone erosion and cartilage damage. MRI is more sensitive than clinical examination for monitoring disease activity (i.e., inflammation) and more sensitive than conventional radiography and ultrasonography for monitoring joint destruction. In suspected RA, MRI bone marrow edema predicts development of RA, and in early RA patients, it predicts subsequent structural damage progression. CT is the standard reference imaging modality for visualizing bone damage, including bone erosions in RA, but lacks sensitivity for soft-tissue changes, including synovitis and tenosynovitis. CT has a minimal role in RA clinical trials and practice, except in selected patients where MRI is contraindicated or not available or if crystal arthritis such as gout or pseudo-gout is suspected. MRI has documented utility in diagnosis, monitoring and prognostication of patients with RA and is increasingly used for these purposes in clinical practice and particularly clinical trials.

Associations between Pain, Synovitis, Bone Marrow Edema, and Sensitization in End-Stage Knee Osteoarthritis

Associations between Pain, Synovitis, Bone Marrow Edema, and Sensitization in End-Stage Knee Osteoarthritis

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Ultrasound Doppler Score Correlates with OMERACT RAMRIS Bone Marrow Oedema and Synovitis Score in the Wrist Joint of Patients with Rheumatoid Arthritis

Ultrasound Doppler Score Correlates with OMERACT RAMRIS Bone Marrow Oedema and Synovitis Score in the Wrist Joint of Patients with Rheumatoid Arthritis

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Changes in Bone Marrow Lesions in Response to Weight-Loss in Obese Knee Osteoarthritis Patients: A Prospective Cohort Study

Changes in Bone Marrow Lesions in Response to Weight-Loss in Obese Knee Osteoarthritis Patients: A Prospective Cohort Study

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Synovial Explant Inflammatory Mediator Production Is Associated With Synovitis While Not With Bone Marrow Edema In Rheumatoid Arthritis: A Cross Sectional Study

Synovial Explant Inflammatory Mediator Production Is Associated With Synovitis While Not With Bone Marrow Edema In Rheumatoid Arthritis: A Cross Sectional Study

Maecenas tempor, ex at maximus efficitur, felis sem ultrices ligula, ut hendrerit purus eros ac urna. Vestibulum ut vestibulum tortor. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Cras eu lectus quam. Nunc ligula arcu, auctor sit amet tellus eleifend, facilisis laoreet odio. Donec placerat urna eleifend blandit porttitor.

Nunc magna turpis, tristique at dictum vel, sollicitudin blandit felis. Morbi aliquam elit et pellentesque vulputate. Donec elementum, ante quis ornare porttitor, tortor dolor vestibulum velit, et viverra enim massa vitae ex.

Correlation Between Computer-Aided Dynamic Gadolinium-Enhanced MRI Assessment of Inflammation and Semi-Quantitative Synovitis and Bone Marrow Oedema Scores of the Wrist in Patients with Rheumatoid Arthritis – A Cohort Study

Correlation Between Computer-Aided Dynamic Gadolinium-Enhanced MRI Assessment of Inflammation and Semi-Quantitative Synovitis and Bone Marrow Oedema Scores of the Wrist in Patients with Rheumatoid Arthritis – A Cohort Study

Maecenas tempor, ex at maximus efficitur, felis sem ultrices ligula, ut hendrerit purus eros ac urna. Vestibulum ut vestibulum tortor. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Cras eu lectus quam. Nunc ligula arcu, auctor sit amet tellus eleifend, facilisis laoreet odio. Donec placerat urna eleifend blandit porttitor.

Nunc magna turpis, tristique at dictum vel, sollicitudin blandit felis. Morbi aliquam elit et pellentesque vulputate. Donec elementum, ante quis ornare porttitor, tortor dolor vestibulum velit, et viverra enim massa vitae ex.