Rheumatoid Arthritis (RA)NCT06783322
Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
An observational study of Rheumatoid Arthritis (RA), run by Diakonhjemmet Hospital at 10 sites in Norway.
Trial summary
The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 259 participants
- Where
- 10 sitesNorway
- Study dates
- Nov 2025to Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of men and women with established rheumatoid arthritis who have experienced sustained remission and participated in the ARCTIC REWIND trial. All the 259 patients that entered the ARCTIC REWIND trial are eligible to participate in the extension study.
Who may be able to join
- Participation in the ARCTIC REWIND trial
- Patients able and willing to give written informed consent and comply with the requirements of the study protocol
Who cannot join
- Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Norway10 sites
Ålesund Hospital
Ålesund
Haukeland University Hospital
Bergen
Vestre Viken Hospital
Drammen
Sørlandet Hospital
Kristiansand
Revmatismesykehuset
Lillehammer
Helgelandssykehuset Mo i Rana
Mo i Rana
Østfold Hospital
Moss
Diakonhjemmet Hospital
Oslo
Martina Hansens Hospital
Sandvika
University Hospital of North Norway
Tromsø
About this study
Official title: The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources.
The investigators will perform an extensive evaluation of all patients who participated in the ARCTIC REWIND study 10 and 15 years after they achieved sustained remission and received different treatment strategies.
Read the detailed description
Rheumatoid Arthritis (RA) is a chronic inflammatory disease that affects 0.5 to 1.0% of the population. In case of ineffective treatment, the inflammation can lead to joint destruction and reduced physical function, as well as affecting internal organs. RA is associated with an increased risk of cardiovascular disease and osteoporosis.
The prognosis for RA has improved significantly over the past two decades, with effective treatment strategies and available drugs allowing a significant proportion of patients to achieve the treatment goal of remission (absence of signs of inflammation). RA has thus become a 'controllable' disease, and the large increase in the number of RA patients in remission leaves a need for improved understanding of how to best treat these patients.
A total of 259 RA patients in sustained remission were included in the ARCTIC REWIND trial. They were randomized to either tapering of DMARDs, or to continue stable DMARD medication, and followed for three years. The current study will provide a 10- and 15-year follow-up on the outcome of all these patients.
The results from the project will add knowledge about the long-term consequences of achieving sustained remission, as well as of experiencing a disease activity flare regarding DMARD use, joint damage progression, functional status and work productivity, and the study will provide novel data on cardiovascular health and other comorbidities in this patient group. Further, the patient perspective on flare will be explored. Such information will be valuable for patients and clinicians to improve shared decision on further treatment, and potentially allow more patients to reduce treatments in an evidence-based manner. Results from the study could influence approaches to the management of RA in the future, as selecting patients who can be switched to remote care (reduce the number of visits the patient has to attend physically).
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- remission, tapering, drug-free remission, long-term outcomes
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity remission status
Remission status will be assessed according to e.g the disease activity score DAS, the Simplified Disease Activity Index (SDAI) and ACR/EULAR Boolean 2.0 remission.
DAS includes the ritchie articular index, the swollen joint count (based on 44 joints), the ESR and the Patient's Global Assessment of disease activity on a VAS 0-100 mm (PGA). The following cut-points are used:
High disease activity: DAS > 3.7; Moderate disease activity: 3.7 ≥ DAS>2.4; Low disease activity: 2.4 ≥ DAS ≥ 1.6; In remission: DAS < 1.6
The SDAI includes tender and swollen joints (of 28), PGA, PhGA and CRP. According to SDAI, the following cut-points are used:
High disease activity: SDAI> 26.0; Moderate disease activity: 26.0 ≥ SDAI>11.0; Low disease activity: 11.0 ≥ SDAI > 3.3; In remission: SDAI ≤ 3.3
ACR/EULAR 2.0 remission is defined as the combination of tender joints ≤ 1, swollen joints ≤ 1, CRP ≤ 1 and patient global assessment ≤ 2 (on a scale 0-10).
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Disease Modifying Anti-Rheumatic Drug (DMARD)-free remission
The prevalence of DMARD-free remission
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Radiographic score (van der Heijde modified Sharp score (vdHSS)
Radiographs of hands and feet. The van der Heijde-modified Sharp scoring method will be used, which assesses erosions in 16 joints of each hand (range, 0-5 for each joint) and in 6 joints of each foot (range, 0-10 per joint) and joint space narrowing in 15 joints for each hand and in 6 joints for each foot (range, 0-4 per joint).This gives scores for erosions on a scale from 0 to 280 and joint space narrowing on a scale from 0 to168, thus the total van der Heijde-modified Sharp score ranges from 0 to 448, with higher scores indicating greater joint damage.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Radiographic joint damage progression
Radiographs of hands and feet. The van der Heijde-modified Sharp scoring method will be used, which assesses erosions in 16 joints of each hand (range, 0-5 for each joint) and in 6 joints of each foot (range, 0-10 per joint) and joint space narrowing in 15 joints for each hand and in 6 joints for each foot (range, 0-4 per joint).This gives scores for erosions on a scale from 0 to 280 and joint space narrowing on a scale from 0 to168, thus the total van der Heijde-modified Sharp score ranges from 0 to 448, with higher scores indicating greater joint damage.
The images will be compared to the last corresponding images undertaken in the ARCTIC REWIND trial.
Progression will be calculated as e.g. annual increase in van der Heijde modified Sharp score ≥ 1 unit.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Disease activity composite measures
The following composite measures will be included: disease activity score (DAS), DAS based on 28 joint counts (DAS28), the simplified disease activity index (SDAI) and the clinical disease activity index (CDAI). These are based on tender and swollen joint counts, the PGA, acute phase reactants (except from CDAI), and, for SDAI and CDAI also the PhGA.
DAS: High disease activity: DAS > 3.7; Moderate disease activity: 3.7 ≥ DAS>2.4; Low disease activity: 2.4 ≥ DAS ≥ 1.6; In remission: DAS < 1.6
DAS28: High disease activity: DAS28 > 5.1; Moderate disease activity: 5.1 ≥ DAS28>3.2; Low disease activity: 3.2 ≥ DAS28 ≥ 2.6; In remission: DAS28 < 2.6
CDAI: High disease activity: CDAI > 22.0; Moderate disease activity: 22.0 ≥ CDAI>10.0; Low disease activity: 10.0 ≥ CDAI > 2.8; In remission: CDAI ≤ 2.8
SDAI: High disease activity: SDAI> 26.0;Moderate disease activity: 26.0 ≥ SDAI>11.0; Low disease activity: 11.0 ≥ SDAI; In remission SDAI ≤ 3.3
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient reported physical function
The Patient-Reported Outcomes Measurement Information (PROMIS) HAQ (Health Assessment Questionnaire ) 20-item short form will be used in this study. Each question has five response options, ranging in value from one to five. To find the total raw score, the sum of the values of the response to each question is calculated, giving a range in scores from 20 to 100 if all questions are answered. The total raw score should be translated into a T-score for each participant (either by standardized conversion tables or using item-level calibrations), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD worse than average.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Secondary outcomes (20)
Health-related quality of life
EuroQol-5 Dimensions three-level (EQ-5D-3L) is a utility instrument for measurement of health-related quality of life. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems (labelled 1-3). They have no arithmetic properties and should not be used to derive a summary score. To derive the summary index score an appropriate value set is required, which provides values (weights) for each health state description according to the preferences of the general population of a country/region
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient global assessment of disease activity
0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Physician global assessment of disease activity
0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Ultrasound inflammation
Ultrasound joint inflammation will be assessed by use of a validated 0-3 semi-quantitative scoring system for power Doppler and grey scale with an ultrasound atlas as reference. In the total ultrasound score 32 joints will be included: Bilateral metacarpophalangeal (MCP) joint I-V, radiocarpal joint, distal radioulnar joint, intercarpal joint, elbow, knee, talocrural joint and metatarsophalangeal (MTP) joint I-V, yielding a maximum total score of 96. In addition to the 32 joints the following will be scored: Bilateral proximal Interphalangeal (PIP) 2 and 3 joints, extensor carpi ulnaris tendon and tibialis posterior tendon.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Swollen joint count
Assessment of 44 joints
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Tender joint count
Assessment of 44 tender joints
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Tender joints
Assessed by Ritchie Articular index
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Osteoporosis
Assessed by Dual-energy X-ray absorptiometry (DEXA)
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Medication use
Record of disease modifying antirheumatic drugs including corticosteroids
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Physical and mental health
This will be assessed by The 36-item Short Form Health Survey (SF-36). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health or emotional wellbeing
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient reported impact of disease
Assessed by the Rheumatoid Arthritis Impact of Disease (RAID) score which is a patient-derived composite response index for use in clinical trials in RA. It includes seven domains which are scored between 0 and 10. The domains are given the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%).
The range of the final RAID value is 0-10 where higher scores indicate worse status.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Work performance and status
Work Productivity and Activity Impairment Questionnaire: WPAI:RA. This is a questionnaire that quantifies health-related work productivity loss for those employed. Work time missed (absentism) and reduced on-the-job effectiveness are expressed in percentages. Overall work productivity loss (abstentism and presentism combined) is also expressed in percentages.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Presence of cardiovascular disease and CVD risk
assessed by Systematic Coronary Risk Evaluation 2 (SCORE2), carotid intima-media thickness and plaques, and echocardiography
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Erythrocyte Sedimentation Rate (ESR)
Blood test
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
C-reactive protein (CRP)
Blood test
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patients reported flare
The Outcome Measures in Rheumatology (OMERACT) preliminary Rheumatoid Arthritis Flare Questionnaire version 2.1 will be used. The questionnaire includes information about variables deemed to be of relevance by both patients and health care professionals to describe and define RA flare. It assesses severity and duration of flare, self-management strategies related to flare, pain, function, fatigue, stiffness, participation, coping, and patients' self-assessment of joint tenderness and swelling.
Patients who classifies themselves as flaring rates the severity on a 11-point Numerical Rating Scale (0-10), the higher score the worse.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Registration of comorbidities
Questionnaire about comorbidities, including, but not limited to, cardiovascular/cerebrovascular disease, respiratory disease, diabetes mellitus, hypertension requiring treatment, cancer, fibromyalgia, osteoporosis, depression requiring treatment, joint replacements, hip fractures, and abdominal perforations.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Fatigue
Fatigue is self-reported with use of a visual analogue scale that ranges from 0 to 100 mm, with higher scores indicating more severe fatigue.
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Joint pain
joint pain is self-reported with use of a visual analogue scale that ranges from 0 to 100 mm, with higher scores indicating more severe joint pain
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient's acceptable symptom state
Patient's acceptable symptom state
Measured: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startNov 2025 (estimated)
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, The Research Council of Norway, Olav Thon Foundation
- Responsible party
- Principal investigator, Nina Sundlisæter, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783322
- Sponsor's protocol ID
- DS-00887
- Status last verified
- Feb 2025
- First submitted
- 12 Dec 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
- ClinicalTrials.gov ID
- NCT06783322
- Acronym / sponsor ID
- DS-00887
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- remission, tapering, drug-free remission, long-term outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, The Research Council of Norway, Olav Thon Foundation
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources.
The investigators will perform an extensive evaluation of all patients who participated in the ARCTIC REWIND study 10 and 15 years after they achieved sustained remission and received different treatment strategies.
Detailed description
Rheumatoid Arthritis (RA) is a chronic inflammatory disease that affects 0.5 to 1.0% of the population. In case of ineffective treatment, the inflammation can lead to joint destruction and reduced physical function, as well as affecting internal organs. RA is associated with an increased risk of cardiovascular disease and osteoporosis.
The prognosis for RA has improved significantly over the past two decades, with effective treatment strategies and available drugs allowing a significant proportion of patients to achieve the treatment goal of remission (absence of signs of inflammation). RA has thus become a 'controllable' disease, and the large increase in the number of RA patients in remission leaves a need for improved understanding of how to best treat these patients.
A total of 259 RA patients in sustained remission were included in the ARCTIC REWIND trial. They were randomized to either tapering of DMARDs, or to continue stable DMARD medication, and followed for three years. The current study will provide a 10- and 15-year follow-up on the outcome of all these patients.
The results from the project will add knowledge about the long-term consequences of achieving sustained remission, as well as of experiencing a disease activity flare regarding DMARD use, joint damage progression, functional status and work productivity, and the study will provide novel data on cardiovascular health and other comorbidities in this patient group. Further, the patient perspective on flare will be explored. Such information will be valuable for patients and clinicians to improve shared decision on further treatment, and potentially allow more patients to reduce treatments in an evidence-based manner. Results from the study could influence approaches to the management of RA in the future, as selecting patients who can be switched to remote care (reduce the number of visits the patient has to attend physically).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of men and women with established rheumatoid arthritis who have experienced sustained remission and participated in the ARCTIC REWIND trial. All the 259 patients that entered the ARCTIC REWIND trial are eligible to participate in the extension study.
Key inclusion criteria (2 listed)
- Participation in the ARCTIC REWIND trial
- Patients able and willing to give written informed consent and comply with the requirements of the study protocol
Key exclusion criteria (1 listed)
- Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease activity remission status
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Remission status will be assessed according to e.g the disease activity score DAS, the Simplified Disease Activity Index (SDAI) and ACR/EULAR Boolean 2.0 remission. DAS includes the ritchie articular index, the swollen joint count (based on 44 joints), the ESR and the Patient's Global Assessment of disease activity on a VAS 0-100 mm (PGA). The following cut-points are used: High disease activity: DAS > 3.7; Moderate disease activity: 3.7 ≥ DAS>2.4; Low disease activity: 2.4 ≥ DAS ≥ 1.6; In remission: DAS < 1.6 The SDAI includes tender and swollen joints (of 28), PGA, PhGA and CRP. According to SDAI, the following cut-points are used: High disease activity: SDAI> 26.0; Moderate disease activity: 26.0 ≥ SDAI>11.0; Low disease activity: 11.0 ≥ SDAI > 3.3; In remission: SDAI ≤ 3.3 ACR/EULAR 2.0 remission is defined as the combination of tender joints ≤ 1, swollen joints ≤ 1, CRP ≤ 1 and patient global assessment ≤ 2 (on a scale 0-10).
Disease Modifying Anti-Rheumatic Drug (DMARD)-free remission
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
The prevalence of DMARD-free remission
Radiographic score (van der Heijde modified Sharp score (vdHSS)
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Radiographs of hands and feet. The van der Heijde-modified Sharp scoring method will be used, which assesses erosions in 16 joints of each hand (range, 0-5 for each joint) and in 6 joints of each foot (range, 0-10 per joint) and joint space narrowing in 15 joints for each hand and in 6 joints for each foot (range, 0-4 per joint).This gives scores for erosions on a scale from 0 to 280 and joint space narrowing on a scale from 0 to168, thus the total van der Heijde-modified Sharp score ranges from 0 to 448, with higher scores indicating greater joint damage.
Radiographic joint damage progression
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Radiographs of hands and feet. The van der Heijde-modified Sharp scoring method will be used, which assesses erosions in 16 joints of each hand (range, 0-5 for each joint) and in 6 joints of each foot (range, 0-10 per joint) and joint space narrowing in 15 joints for each hand and in 6 joints for each foot (range, 0-4 per joint).This gives scores for erosions on a scale from 0 to 280 and joint space narrowing on a scale from 0 to168, thus the total van der Heijde-modified Sharp score ranges from 0 to 448, with higher scores indicating greater joint damage. The images will be compared to the last corresponding images undertaken in the ARCTIC REWIND trial. Progression will be calculated as e.g. annual increase in van der Heijde modified Sharp score ≥ 1 unit.
Disease activity composite measures
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
The following composite measures will be included: disease activity score (DAS), DAS based on 28 joint counts (DAS28), the simplified disease activity index (SDAI) and the clinical disease activity index (CDAI). These are based on tender and swollen joint counts, the PGA, acute phase reactants (except from CDAI), and, for SDAI and CDAI also the PhGA. DAS: High disease activity: DAS > 3.7; Moderate disease activity: 3.7 ≥ DAS>2.4; Low disease activity: 2.4 ≥ DAS ≥ 1.6; In remission: DAS < 1.6 DAS28: High disease activity: DAS28 > 5.1; Moderate disease activity: 5.1 ≥ DAS28>3.2; Low disease activity: 3.2 ≥ DAS28 ≥ 2.6; In remission: DAS28 < 2.6 CDAI: High disease activity: CDAI > 22.0; Moderate disease activity: 22.0 ≥ CDAI>10.0; Low disease activity: 10.0 ≥ CDAI > 2.8; In remission: CDAI ≤ 2.8 SDAI: High disease activity: SDAI> 26.0;Moderate disease activity: 26.0 ≥ SDAI>11.0; Low disease activity: 11.0 ≥ SDAI; In remission SDAI ≤ 3.3
Patient reported physical function
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
The Patient-Reported Outcomes Measurement Information (PROMIS) HAQ (Health Assessment Questionnaire ) 20-item short form will be used in this study. Each question has five response options, ranging in value from one to five. To find the total raw score, the sum of the values of the response to each question is calculated, giving a range in scores from 20 to 100 if all questions are answered. The total raw score should be translated into a T-score for each participant (either by standardized conversion tables or using item-level calibrations), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD worse than average.
20 secondary outcomes
Health-related quality of life
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient global assessment of disease activity
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Physician global assessment of disease activity
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Ultrasound inflammation
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Swollen joint count
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Tender joint count
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Tender joints
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Osteoporosis
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Medication use
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Physical and mental health
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient reported impact of disease
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Work performance and status
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Presence of cardiovascular disease and CVD risk
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Erythrocyte Sedimentation Rate (ESR)
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
C-reactive protein (CRP)
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patients reported flare
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Registration of comorbidities
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Fatigue
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Joint pain
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Patient's acceptable symptom state
Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by Diakonhjemmet Hospital at 10 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Paulshus Sundlisæter, MD PhD (+47 22451500, ninasundlisater@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity remission status (time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.