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Rheumatoid ArthritisARCTIC-FORWARDNCT05304013

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

An observational study of Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 11 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
180 participants
Where
11 sitesNorway
Study dates
22 Dec 2021to 15 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with established Rheumatoid arthritis who participated in the ARCTIC trial

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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Norway11 sites

  • Ålesund Hospital

    Ålesund

  • Haukeland University Hospital

    Bergen, 5021

  • Vestre Viken Hospital

    Drammen

  • Haugesund Hospital, Helse Fonna

    Haugesund

  • Sørlandet Hospital

    Kristiansand, 4615

  • Revmatolog Anne Lindtner Noraas

    Kristiansand

  • Østfold Hospital

    Moss, 1535

  • Diakonhjemmet Hospital

    Oslo

  • University Hospital of North Norway

    Tromsø

  • St. Olavs hospital (Trondheim University hospital)

    Trondheim

  • Martina Hansens Hospital

    Viken

Other trials in Norway

About this study

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.

Read the detailed description

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.

Keywords
Long-term outcomes, Extra-articular manifestations
Medical subject headings
Arthritis, Rheumatoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression of radiographs joint damage

    Radiographs of hands and feet

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

  2. Disease activity

    Assessed by the disease activity score (DAS)

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

  3. Disease activity remission

    Remission based on disease activity score (DAS)

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

  4. Physical and mental health

    Assessed by SF-36

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

Secondary outcomes (20)

  1. Ultrasound inflammation

    Power doppler and B-mode

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

  2. Grip strength

    Measured by dynamometer

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

  3. Patient reported impact of disease

    RAID

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

  4. Swollen joint count

    44 joints

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

  5. Tender joint count

    28 joints

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

  6. Tender joints

    Assessed by Ritchie Articular index

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

  7. Comorbidities

    Questionnaire

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

  8. C-reactive protein (CRP)

    Blood test

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

  9. Erythrocyte sedimentation rate (ESR)

    Blood test

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

  10. Presence of rheumatoid noduli

    Skin examination

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

  11. Osteoporosis

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

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

  12. Medication use

    Record of disease modifying drugs antirheumatic drugs including corticosteroids

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

  13. Patient global assessment of disease activity

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

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

  14. Physician global assessment of disease activity

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

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

  15. Interstitial lung disease

    Assessed by HRCT

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

  16. Physical activity level

    Assessed by accelerometer

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

  17. Patient reported Physical function

    Assessed by HAQ-PROMIS

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

  18. Health-related quality of life

    Assessed by EQ-5D

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

  19. Work Productivity

    Work Productivity and Activity Impairment Questionnaire: WPAI:RA

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

  20. Pulmonary function

    Spirometry and DLCO

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start22 Dec 2021
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304013
Sponsor's protocol ID
DIA2021-1/ver 1
Acronym
ARCTIC-FORWARD
Status last verified
Oct 2024
First submitted
22 Mar 2022
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 11 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of radiographs joint damage (time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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