The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis (RA).
Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Patients typically experience pain, functional impairment and reduced quality of life, and are at risk of developing progressive joint damage. The disease primarily affects the small joints of the hands and feet. The current treatment strategy involves early and intensive treatment with close clinical follow up, which attempts to control the disease and avoid inflammation and thereby prevent pain, improve functional level and avoid joint damage. It is therefore important for optimal treatment of RA patients that methods used for diagnosis, disease monitoring and prognostication are highly sensitive. Erosive joint damage occurs early in the disease. Joint deformity is irreversible and causes serious functional impairment. Early and intensive treatment with close monitoring of the inflammation can slow the destructive disease and prevent function loss. However, it has been demonstrated that patients who are shown by conventional clinical and biochemical examination to have low disease activity or to be in remission can still have progressive joint damage. This demonstrates that current clinical/biochemical methods used in daily clinical practice are not sufficiently sensitive and other methods are required for the monitoring of disease activity and prognostication. The presence of erosions (shown by X-ray examination) as well as anti-cyclic citrullinated peptide (anti-CCP) antibodies and bone marrow oedema (osteitis) on magnetic resonance imaging (MRI), are all independent predictors of subsequent radiographic progression. Bone marrow oedema has been shown to be the strongest independent predictor in early RA and MRI therefore has significant prognostic value. It is therefore possible that supplementing conventional clinical and biochemical examinations of RA patients with MRI, and intensifying treatment where bone marrow oedema is present, will help reduce disease activity, avoid progressive joint damage and prevent function loss. The current study is therefore based on the following hypothesis: By supplementing conventional clinical and biochemical examination of RA patients with low disease activity/in remission with MRI and intensifying treatment in the case of sub-clinical inflammation as measured by the presence of bone marrow oedema, it is possible to prevent radiographic erosive progression, improve functional level and enable more patients to achieve clinical remission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one physically swollen joint and DAS28\>3.2 AND/OR MRI-detected bone marrow oedema score \> 0 (RAMRIS-score)
Treatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one clinically swollen joint and DAS28\>3.2
Dep. of Rheumatology Aarhus Hospital
Aarhus, Denmark
Dep. of Rheumatology Frederiksberg Hospital
Copenhagen, Denmark
Dep. of Rheumatology Glostrup Hospital
Copenhagen, Denmark
Dep. of Rheumatology Gentofte Hospital
Copenhagen, Denmark
Dep. of Rheumatology King Christian X´Hospital for Rheumatic Diseases
Gråsten, Denmark
Department of Rheumatology University Hospital Vendsyssel
Hjørring, Denmark
Dep. of rheumatology Odense Hospital
Odense, Denmark
Dep. of Rheumatology Silkeborg Hospital
Silkeborg, Denmark
Dep. of Rheumatology Slagelse Hospital
Slagelse, Denmark
DAS28 remission (<2.6)
Time frame: 24 month
No radiographic progression (assessed by the Sharp/vdHeijde method).
Time frame: 24 month
No radiographic progression (Sharp/vdHeijde score).
No radiographic progression (Sharp/vdHeijde score) from 0-12 and 12-24 months and change in Sharp/vdHeijde score from 0-12, 0-24 and 12-24 months.
Time frame: 24 month
No MRI erosion (RAMRIS) score
No progression in MRI erosion (RAMRIS) score from 0-12 and 12-24 months and change in MRI erosion (RAMRIS) score from 0-12, 0-24 and 12-24 months.
Time frame: 24 month
MRI synovitis (RAMRIS) score
MRI synovitis (RAMRIS) score at 12 and 24 months
Time frame: 24 months
MRI bone marrow oedema (RAMRIS) score
MRI bone marrow oedema (RAMRIS) score at 12 and 24 months
Time frame: 24 months
HAQ score
Changes in HAQ score from 0-12 and 0-24 months
Time frame: 24 month
SF-36 score
Changes in SF-36 score from 0-12 and 0-24 months
Time frame: 24 month
EQ-5D score
Changes in EQ-5D score from 0-12 and 0-24 months
Time frame: 24 month
ACR/EULAR 2011 remission
ACR/EULAR 2011 remission at 12 and 24 months
Time frame: 24 month
DAS28
DAS28 at 12 and 24 month
Time frame: 24 month
DAS28 remission (<2.6) at 12 months
Time frame: 24 months
biomarker analyses
Time frame: 24 month
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