Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial (ARCTIC)
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| ClinicalTrials.gov Identifier: NCT01205854 |
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Recruitment Status :
Completed
First Posted : September 21, 2010
Last Update Posted : April 16, 2015
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Sponsor:
Espen A. Haavardsholm
Collaborators:
The Research Council of Norway
Smerud Medical Research International AS
Oslo University Hospital
Innovest
Abbott
UCB Nordic A/S
Pfizer
MSD Norway AS
Roche Pharma AG
The Norwegian Rheumatism Association
Information provided by (Responsible Party):
Espen A. Haavardsholm, Diakonhjemmet Hospital
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Device: Ultrasonography | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 238 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Aiming for Remission in Rheumatoid Arthritis: a Randomized Trial Examining the Benefit of Ultrasonography in a Clinical TIght Control Regimen |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Conventional clinical and laboratory assessment | |
| Experimental: Conventional assessment plus ultrasonography |
Device: Ultrasonography
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. |
Primary Outcome Measures :
- Complete clinical Disease Activity Score (DAS) remission [ Time Frame: 24 months ]
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)
Secondary Outcome Measures :
- Magnetic Resonance Imaging (MRI) of dominant hand [ Time Frame: 24 months ]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.
- American College of Rheumatology (ACR) response [ Time Frame: 24 months ]Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.
- Remission [ Time Frame: 24 months ]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
- European League Against Rheumatism (EULAR) response [ Time Frame: 24 months ]EULAR good, moderate and non-response
- Work performance [ Time Frame: 24 months ]
- Absenteeism (work time missed)
- Presenteeism (impairment at work / reduced on-the-job effectiveness)
- Work productivity loss (overall work impairment / absenteeism plus presenteeism)
- Activity Impairment
- Conventional radiography [ Time Frame: 24 months ]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.
- The RA Impact of Disease (RAID) score [ Time Frame: 24 months ]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%).
- EuroQol-5 Dimension (EQ-5D) [ Time Frame: 24 months ]EQ-5D is a standardised instrument for use as a measure of health outcome.
- Health Assessment Questionnaire (HAQ-PROMIS) [ Time Frame: 24 months ]The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.
- Medical Outcomes Study Short-Form 36-item (SF-36) [ Time Frame: 24 months ]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.
- Dual Energy X-ray Absorptiometry (DEXA) of spine and hip [ Time Frame: 24 months ]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.
- Disease Activity Score (DAS) [ Time Frame: 24 months ]
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
- Ultrasonography (synovitis) [ Time Frame: 24 months ]36 joints and 2 tendons will be scored for both grey scale and power doppler synovitis on a 0-3 scale.
- Magnetic Resonance Imaging (MRI) of dominant hand [ Time Frame: 12 months ]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.
- American College of Rheumatology (ACR) response [ Time Frame: 12 months ]Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.
- European League Against Rheumatism (EULAR) response [ Time Frame: 12 months ]EULAR good, moderate and non-response
- Remission [ Time Frame: 12 months ]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
- Work performance [ Time Frame: 12 months ]
- Absenteeism (work time missed)
- Presenteeism (impairment at work / reduced on-the-job effectiveness)
- Work productivity loss (overall work impairment / absenteeism plus presenteeism)
- Activity Impairment
- Conventional radiography [ Time Frame: 12 months ]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.
- The RA Impact of Disease (RAID) score [ Time Frame: 12 months ]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%).
- Health Assessment Questionnaire (HAQ-PROMIS) [ Time Frame: 12 months ]The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.
- Medical Outcomes Study Short-Form 36-item (SF-36) [ Time Frame: 12 months ]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.
- Dual Energy X-ray Absorptiometry (DEXA) of spine and hip [ Time Frame: 12 months ]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.
- Ultrasonography (synovitis) [ Time Frame: 12 months ]36 joints and 2 tendons will be scored for both grey scale and power doppler synovitis on a 0-3 scale.
- Disease Activity Score (DAS) [ Time Frame: 12 months ]
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
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria (all):
- Male or non-pregnant, non-nursing female
- > 18 years of age and < 75 years of age
- Patients classified as having RA (according to new ACR/EULAR criteria)
- Disease duration less than 2 years (defined as time from 1st joint swelling)
- The treating rheumatologist decides the patient requires treatment with a Disease Modifying Anti-Rheumatic Drug (DMARD)
- The patient has taken no prior DMARD
- Patients able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion Criteria (any):
- Abnormal renal function (serum creatinine > 142 µmol/L in female and > 168 µmol/L in male)
- Abnormal liver function, active or recent hepatitis, cirrhosis
- Major co-morbidities like severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease and/or severe respiratory diseases.
- Leukopenia and/or thrombocytopenia
- Inadequate birth control conception, pregnancy, and/or breastfeeding
- Indications of active tuberculosis
- Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205854
Locations
| Norway | |
| Martina Hansens Hospital AS | |
| Sandvika, Bærum, Norway, 1306 | |
| Sykehuset Østfold HF, Dept. of Rheumatology | |
| Moss, Fredrikstad, Norway, 1603 | |
| Helse Bergen HF, Haukeland University Hospital, Dept. of Rheumatology | |
| Bergen, Norway, 5021 | |
| Vestre Viken HF, Dept. of Rheumatology | |
| Drammen, Norway, 3004 | |
| Haugesund Sanitetsforening Revmatismesykehus | |
| Haugesund, Norway, 5504 | |
| Sørlandet Sykehus HF, Dept. of Rheumatology | |
| Kristiansand, Norway, 4604 | |
| Revmatologene bendvold/Dovland | |
| Kristiansand, Norway, 4611 | |
| Diakonhjemmet Sykehus AS, Dept. of Rheumatology | |
| Oslo, Norway, 0319 | |
| Universitetssykehuset Nord-Norge HF, Dept. of Rheumatology | |
| Tromsø, Norway, 9038 | |
| St Olavs Hospital HF, Dept. of Rheumatology | |
| Trondheim, Norway, 7006 | |
| Helse Sunnmøre HF, Dept. of Rheumatology | |
| Ålesund, Norway, 6026 | |
Sponsors and Collaborators
Espen A. Haavardsholm
The Research Council of Norway
Smerud Medical Research International AS
Oslo University Hospital
Innovest
Abbott
UCB Nordic A/S
Pfizer
MSD Norway AS
Roche Pharma AG
The Norwegian Rheumatism Association
Investigators
| Study Director: | Tore K Kvien, MD, PhD | Diakonhjemmet Hospital AS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Espen A. Haavardsholm, Post. doctoral Researcher, MD Ph.D., Diakonhjemmet Hospital |
| ClinicalTrials.gov Identifier: | NCT01205854 |
| Other Study ID Numbers: |
DIA2010-1 |
| First Posted: | September 21, 2010 Key Record Dates |
| Last Update Posted: | April 16, 2015 |
| Last Verified: | April 2015 |
Keywords provided by Espen A. Haavardsholm, Diakonhjemmet Hospital:
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rheumatoid arthritis ultrasonography remission |
imaging remission tight control treat to target |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |