10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease

NCT ID: NCT05304013

Last Updated: 2024-10-04

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

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-22

Study Completion Date

2024-08-15

Brief Summary

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The ARCTIC-FORWARD study is a multi-center prospective observational study investigating the long-term outcomes of rheumatoid arthritis (RA) patients who received structured treat-to-target therapy early in their disease. The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs.

Detailed Description

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Rheumatoid arthritis (RA) is one of the most common autoimmune diseases. Recent developments in RA treatment has shown to change the outcome of RA for the early stages of the disease, with very limited loss of work participation and high rates of disease activity remission. The data on the long-term outcome for patients who received early optimal treatment is much more limited, and it is of special clinical interest to know to what extent these patients should be monitored with regards to slowly evolving joint damage, subclinical inflammation, loss of physical function and loss of work participation.

The aim of this study is to assess clinical, radiographic and functional long-term outcomes of modern RA care and to identify risk factors for progressive disease.The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs. We will perform an extensive evaluation of all patients participating in the ARCTIC study 10 years after the initiation of structured treat-to-target therapy. Outcomes include disease activity, radiographic damage, functional status, DMARD use, extra-articular manifestations including interstitial lung disease, comorbidities, survival, work participation, health care resource use, and health related quality of life.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: All patients that entered the ARCTIC study are eligible for the follow-up study. The main inclusion criteria in the ARCTIC study were age 18-75 years, fulfilment of the 2010 ACR classification criteria for RA, DMARD naivety with indication from DMARD therapy, and symptom duration of less than two years.

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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Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Siri Lillegraven

Senior researcher, Leader of Unit for clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siri Lillegraven, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Hospital

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

Haugesund Hospital, Helse Fonna

Haugesund, , Norway

Site Status

Sørlandet Hospital

Kristiansand, , Norway

Site Status

Revmatolog Anne Lindtner Noraas

Kristiansand, , Norway

Site Status

Østfold Hospital

Moss, , Norway

Site Status

Diakonhjemmet Hospital

Oslo, , Norway

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

St. Olavs hospital (Trondheim University hospital)

Trondheim, , Norway

Site Status

Martina Hansens Hospital

Viken, , Norway

Site Status

Countries

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Norway

Other Identifiers

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DIA2021-1/ver 1

Identifier Type: -

Identifier Source: org_study_id

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