The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known. Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US leads to better care for RA patients. This study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Standardized ultrasonographic assessment of 32 joints, assessed for both grey scale synovitis and power doppler signal, at each visit. Dose escalations based on DAS response in combination with change in US score. All joints with US Power Doppler signal are targets for intra articular injections.
Helse Bergen HF, Haukeland University Hospital, Dept. of Rheumatology
Bergen, Bergen, Norway
Martina Hansens Hospital AS
Sandvika, Bærum, Norway
Vestre Viken HF, Dept. of Rheumatology
Drammen, Drammen, Norway
Sykehuset Østfold HF, Dept. of Rheumatology
Moss, Fredrikstad, Norway
Haugesund Sanitetsforening Revmatismesykehus
Haugesund, Haugesund, Norway
Sørlandet Sykehus HF, Dept. of Rheumatology
Kristiansand, Kristiansand, Norway
Diakonhjemmet Sykehus AS, Dept. of Rheumatology
Oslo, Oslo, Norway
Universitetssykehuset Nord-Norge HF, Dept. of Rheumatology
Tromsø, Tromsø, Norway
St Olavs Hospital HF, Dept. of Rheumatology
Trondheim, Trondheim, Norway
Revmatologene bendvold/Dovland
Kristiansand, Norway
...and 1 more locations
Complete clinical Disease Activity Score (DAS) remission
Specifically, the primary endpoint will be the proportion of patients with all the following criteria met at the end of the study (at 24 months): * DAS score \< 1.6 at visits 11, 12 and 13 (after 16, 20 and 24 months) * Absence of swollen joints at visits 11, 12 and 13 (after 16, 20 and 24 months) * No radiological progression between visit 11 (16 months) and visit 13 (24 months)
Time frame: 24 months
Magnetic Resonance Imaging (MRI) of dominant hand
MRIs of dominant hand are scored according to the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) for synovitis, bone marrow edema and erosions, and Haavardsholm tenosynovitis score, as well as a novel joint space narrowing score will be applied.
Time frame: 24 months
American College of Rheumatology (ACR) response
Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.
Time frame: 24 months
Remission
Various definitions of remission will be calculated, including DAS-remission, ACR-remission, Simplified Diseases Activity Index (SDAI) remission and Clinical Disease Activity Index (CDAI) remission
Time frame: 24 months
European League Against Rheumatism (EULAR) response
EULAR good, moderate and non-response
Time frame: 24 months
Work performance
1. Absenteeism (work time missed) 2. Presenteeism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment
Time frame: 24 months
Conventional radiography
Radiographs of hands (posterior/anterior) and foot (anterior/posterior) will be taken at baseline, 3, 6, 12, 16 and 24 months. The modified Sharp van der Heijde Score (vdHSS) will be calculated, including an erosion score and a joint space narrowing score.
Time frame: 24 months
The RA Impact of Disease (RAID) score
The RAID includes seven domains with the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%).
Time frame: 24 months
EuroQol-5 Dimension (EQ-5D)
EQ-5D is a standardised instrument for use as a measure of health outcome.
Time frame: 24 months
Health Assessment Questionnaire (HAQ-PROMIS)
The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.
Time frame: 24 months
Medical Outcomes Study Short-Form 36-item (SF-36)
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Time frame: 24 months
Dual Energy X-ray Absorptiometry (DEXA) of spine and hip
Bone density measurements (DEXA hip and spine, both Z- and T-scores as well as bone mineral density) will be performed at baseline and after 12 and 24 months.
Time frame: 24 months
Disease Activity Score (DAS)
The DAS is a composite score that includes the Ritchie articular index (RAI), the 44- swollen joint counts (SJC-44), the Erythrocyte Sedimentation Rate (ESR) and a general health (GH) assessment on a Visual Analogue Scale (VAS). The DAS is calculated as follows: DAS = 0.54\*sqrt(RAI) + 0.065\*(SJC-44) + 0.33\*Ln(ESR) + 0.0072\*GH
Time frame: 24 months
Ultrasonography (synovitis)
36 joints and 2 tendons will be scored for both grey scale and power doppler synovitis on a 0-3 scale.
Time frame: 24 months
Magnetic Resonance Imaging (MRI) of dominant hand
MRIs of dominant hand are scored according to the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) for synovitis, bone marrow edema and erosions, and Haavardsholm tenosynovitis score, as well as a novel joint space narrowing score will be applied.
Time frame: 12 months
American College of Rheumatology (ACR) response
Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.
Time frame: 12 months
European League Against Rheumatism (EULAR) response
EULAR good, moderate and non-response
Time frame: 12 months
Remission
Various definitions of remission will be calculated, including DAS-remission, ACR-remission, Simplified Diseases Activity Index (SDAI) remission and Clinical Disease Activity Index (CDAI) remission
Time frame: 12 months
Work performance
1. Absenteeism (work time missed) 2. Presenteeism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment
Time frame: 12 months
Conventional radiography
Radiographs of hands (posterior/anterior) and foot (anterior/posterior) will be taken at baseline, 3, 6 and 12 months. The modified Sharp van der Heijde Score (vdHSS) will be calculated, including an erosion score and a joint space narrowing score.
Time frame: 12 months
The RA Impact of Disease (RAID) score
The RAID includes seven domains with the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%).
Time frame: 12 months
Health Assessment Questionnaire (HAQ-PROMIS)
The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.
Time frame: 12 months
Medical Outcomes Study Short-Form 36-item (SF-36)
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Time frame: 12 months
Dual Energy X-ray Absorptiometry (DEXA) of spine and hip
Bone density measurements (DEXA hip and spine, both Z- and T-scores as well as bone mineral density) will be performed at baseline and after 12 and 24 months.
Time frame: 12 months
Ultrasonography (synovitis)
36 joints and 2 tendons will be scored for both grey scale and power doppler synovitis on a 0-3 scale.
Time frame: 12 months
Disease Activity Score (DAS)
The DAS is a composite score that includes the Ritchie articular index (RAI), the 44- swollen joint counts (SJC-44), the Erythrocyte Sedimentation Rate (ESR) and a general health (GH) assessment on a Visual Analogue Scale (VAS). The DAS is calculated as follows: DAS = 0.54\*sqrt(RAI) + 0.065\*(SJC-44) + 0.33\*Ln(ESR) + 0.0072\*GH
Time frame: 12 months
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