The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 259
- Locations
- 10
- Primary Endpoint
- Disease activity remission status
Study Overview
Brief 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 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participation in the ARCTIC REWIND trial
- •Patients able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion Criteria
- •Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Osteoporosis(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Health-related quality of life(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Tender joint count(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Patient global assessment of disease activity(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Physician global assessment of disease activity(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Ultrasound inflammation(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Swollen joint count(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Tender joints(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Medication use(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Physical and mental health(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Patient reported impact of disease(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Work performance and status(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 at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Erythrocyte Sedimentation Rate (ESR)(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- C-reactive protein (CRP)(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Patients reported flare(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Registration of comorbidities(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Fatigue(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Joint pain(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
- Patient's acceptable symptom state(Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial)
Investigators
Nina Sundlisæter
PhD
Diakonhjemmet Hospital