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Trial record 1 of 1 for:    NCT01205854
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Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial (ARCTIC)

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ClinicalTrials.gov Identifier: NCT01205854
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : April 16, 2015
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE September 16, 2010
First Posted Date  ICMJE September 21, 2010
Last Update Posted Date April 16, 2015
Study Start Date  ICMJE September 2010
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2010)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2010)
  • 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 ]
    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
  • 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 ]
    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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial
Official Title  ICMJE Aiming for Remission in Rheumatoid Arthritis: a Randomized Trial Examining the Benefit of Ultrasonography in a Clinical TIght Control Regimen
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Conventional clinical and laboratory assessment
  • Experimental: Conventional assessment plus ultrasonography
    Intervention: Device: Ultrasonography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2015)
238
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2010)
240
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01205854
Other Study ID Numbers  ICMJE DIA2010-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Espen A. Haavardsholm, Diakonhjemmet Hospital
Study Sponsor  ICMJE Espen A. Haavardsholm
Collaborators  ICMJE
  • 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  ICMJE
Study Director: Tore K Kvien, MD, PhD Diakonhjemmet Hospital AS
PRS Account Diakonhjemmet Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP