Clinical trial NCT06783322: Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
Official title: The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis (RA)
Keywords: remission
tapering
drug-free remission
long-term outcomes
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: The Research Council of Norway
name: Olav Thon Foundation
First posted: 2025-01-20
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

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.

Primary outcomes:
measure: Disease activity remission status
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Disease Modifying Anti-Rheumatic Drug (DMARD)-free remission
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Radiographic score (van der Heijde modified Sharp score (vdHSS)
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Radiographic joint damage progression
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Disease activity composite measures
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Patient reported physical function
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Patient global assessment of disease activity
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Physician global assessment of disease activity
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Ultrasound inflammation
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Swollen joint count
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Tender joint count
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Tender joints
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Osteoporosis
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Medication use
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Physical and mental health
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Patient reported impact of disease
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Work performance and status
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Presence of cardiovascular disease and CVD risk
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: C-reactive protein (CRP)
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Patients reported flare
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Registration of comorbidities
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Fatigue
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Joint pain
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
measure: Patient's acceptable symptom state
timeFrame: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken Hospital
city: Kristiansand
country: Norway
facility: Sørlandet Hospital
city: Lillehammer
country: Norway
facility: Revmatismesykehuset
city: Mo i Rana
country: Norway
facility: Helgelandssykehuset Mo i Rana
city: Moss
country: Norway
facility: Østfold Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
References: