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
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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
Originalsprog | Engelsk |
---|---|
Tidsskrift | Trials |
Vol/bind | 16 |
Udgave nummer | 178 |
Sider (fra-til) | 1-11 |
Antal sider | 11 |
ISSN | 1745-6215 |
DOI | |
Status | Udgivet - 2015 |
ID: 159107878