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NCT Number: NCT01205854

Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helse Bergen HF, Haukeland University Hospital, Dept. of Rheumatology, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonography

Device

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 outcomes

  1. 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 outcomes

  1. 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.

  2. American College of Rheumatology (ACR) response

    Time frame: 24 months

    Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.

  3. 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

  4. European League Against Rheumatism (EULAR) response

    Time frame: 24 months

    EULAR good, moderate and non-response

  5. 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

  6. 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.

  7. 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%).

  8. EuroQol-5 Dimension (EQ-5D)

    Time frame: 24 months

    EQ-5D is a standardised instrument for use as a measure of health outcome.

  9. Health Assessment Questionnaire (HAQ-PROMIS)

    Time frame: 24 months

    The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. American College of Rheumatology (ACR) response

    Time frame: 12 months

    Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.

  16. European League Against Rheumatism (EULAR) response

    Time frame: 12 months

    EULAR good, moderate and non-response

  17. 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

  18. 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

  19. 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.

  20. 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%).

  21. Health Assessment Questionnaire (HAQ-PROMIS)

    Time frame: 12 months

    The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.

  22. 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.

  23. 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.

  24. 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.

  25. 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

Sponsors and collaborators

Lead sponsor

Espen A. Haavardsholm

Other

Collaborators

  • Abbott
  • Innovest
  • MSD Norway AS
  • Oslo University Hospital
  • Pfizer
  • Roche Pharma AG
  • Smerud Medical Research International AS
  • The Norwegian Rheumatism Association
  • The Research Council of Norway
  • UCB Nordic A/S

Registry information

Official study title

Aiming for Remission in Rheumatoid Arthritis: a Randomized Trial Examining the Benefit of Ultrasonography in a Clinical TIght Control Regimen

Acronym: ARCTIC

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2010
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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