Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission

NCT ID: NCT06783322

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2034-01-31

Brief Summary

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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

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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

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Rheumatoid Arthritis (RA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

The Research Council of Norway

OTHER

Sponsor Role collaborator

Olav Thon Foundation

UNKNOWN

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nina Sundlisæter

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ålesund Hospital

Ålesund, , Norway

Site Status

Haukeland University Hospital

Bergen, , Norway

Site Status

Vestre Viken Hospital

Drammen, , Norway

Site Status

Sørlandet Hospital

Kristiansand, , Norway

Site Status

Revmatismesykehuset

Lillehammer, , Norway

Site Status

Helgelandssykehuset Mo i Rana

Mo i Rana, , Norway

Site Status

Østfold Hospital

Moss, , Norway

Site Status

Diakonhjemmet Hospital

Oslo, , Norway

Site Status

Martina Hansens Hospital

Sandvika, , Norway

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

Central Contacts

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Nina Paulshus Sundlisæter, MD PhD

Role: CONTACT

+47 22451500

Other Identifiers

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DS-00887

Identifier Type: -

Identifier Source: org_study_id

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