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Completed

NCT Number: NCT05304013

10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease

The ARCTIC-FORWARD study is a multi-center prospective observational study investigating the long-term outcomes of rheumatoid arthritis (RA) patients who received structured treat-to-target therapy early in their disease. The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

Rheumatoid arthritis (RA) is one of the most common autoimmune diseases. Recent developments in RA treatment has shown to change the outcome of RA for the early stages of the disease, with very limited loss of work participation and high rates of disease activity remission. The data on the long-term outcome for patients who received early optimal treatment is much more limited, and it is of special clinical interest to know to what extent these patients should be monitored with regards to slowly evolving joint damage, subclinical inflammation, loss of physical function and loss of work participation.

The aim of this study is to assess clinical, radiographic and functional long-term outcomes of modern RA care and to identify risk factors for progressive disease.The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs. We will perform an extensive evaluation of all patients participating in the ARCTIC study 10 years after the initiation of structured treat-to-target therapy. Outcomes include disease activity, radiographic damage, functional status, DMARD use, extra-articular manifestations including interstitial lung disease, comorbidities, survival, work participation, health care resource use, and health related quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients that entered the ARCTIC study are eligible for the follow-up study. The main inclusion criteria in the ARCTIC study were age 18-75 years, fulfilment of the 2010 ACR classification criteria for RA, DMARD naivety with indication from DMARD therapy, and symptom duration of less than two years.

Exclusion criteria

Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible

Treatment and study plan

Primary outcomes

  1. Progression of radiographs joint damage

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Radiographs of hands and feet

  2. Disease activity

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by the disease activity score (DAS)

  3. Disease activity remission

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Remission based on disease activity score (DAS)

  4. Physical and mental health

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by SF-36

Secondary outcomes

  1. Ultrasound inflammation

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Power doppler and B-mode

  2. Grip strength

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Measured by dynamometer

  3. Patient reported impact of disease

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    RAID

  4. Swollen joint count

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    44 joints

  5. Tender joint count

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    28 joints

  6. Tender joints

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by Ritchie Articular index

  7. Comorbidities

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Questionnaire

  8. C-reactive protein (CRP)

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Blood test

  9. Erythrocyte sedimentation rate (ESR)

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Blood test

  10. Presence of rheumatoid noduli

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Skin examination

  11. Osteoporosis

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by Dual-energy X-ray absorptiometry (DEXA)

  12. Medication use

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Record of disease modifying drugs antirheumatic drugs including corticosteroids

  13. Patient global assessment of disease activity

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity

  14. Physician global assessment of disease activity

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity

  15. Interstitial lung disease

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by HRCT

  16. Physical activity level

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by accelerometer

  17. Patient reported Physical function

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by HAQ-PROMIS

  18. Health-related quality of life

    Time frame: 10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Assessed by EQ-5D

  19. Work Productivity

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Work Productivity and Activity Impairment Questionnaire: WPAI:RA

  20. Pulmonary function

    Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)

    Spirometry and DLCO

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Acronym: ARCTIC-FORWARD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Oct 4, 2024

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

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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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