Clinical trial NCT05304013: 10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease
Official title: 10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Long-term outcomes
Extra-articular manifestations
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 180
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: Patients with established Rheumatoid arthritis who participated in the ARCTIC trial

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Progression of radiographs joint damage
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Disease activity
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Disease activity remission
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Physical and mental health
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary outcomes:
measure: Ultrasound inflammation
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Grip strength
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Patient reported impact of disease
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Swollen joint count
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Tender joint count
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Tender joints
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Comorbidities
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: C-reactive protein (CRP)
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Presence of rheumatoid noduli
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Osteoporosis
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Medication use
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Patient global assessment of disease activity
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Physician global assessment of disease activity
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Interstitial lung disease
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Physical activity level
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Patient reported Physical function
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Health-related quality of life
timeFrame: 10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Work Productivity
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
measure: Pulmonary function
timeFrame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken Hospital
city: Haugesund
country: Norway
facility: Haugesund Hospital, Helse Fonna
city: Kristiansand
country: Norway
facility: Sørlandet Hospital
city: Kristiansand
country: Norway
facility: Revmatolog Anne Lindtner Noraas
city: Moss
country: Norway
facility: Østfold Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs hospital (Trondheim University hospital)
city: Viken
country: Norway
facility: Martina Hansens Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Siri Lillegraven, PhD
role: PRINCIPAL_INVESTIGATOR
References: