Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
Overview
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).
Primary outcome measures
- Disease activity remission status [Time frame: 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 [Time frame: 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) [Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Radiographic joint damage progression [Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Disease activity composite measures [Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Patient reported physical function [Time frame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 10 centers
- 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
- … and 2 more centers
Identifiers
NCT: NCT06783322 · DS-00887