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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT05304013
• Lead Sponsor: Diakonhjemmet Hospital

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.

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of radiographs joint damage	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Radiographs of hands and feet
Disease activity remission	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Remission based on disease activity score (DAS)
Disease activity	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by the disease activity score (DAS)
Physical and mental health	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by SF-36

Secondary Outcome Measures

Name	Time	Method
Tender joints	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by Ritchie Articular index
Osteoporosis	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by Dual-energy X-ray absorptiometry (DEXA)
Physician global assessment of disease activity	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity
Health-related quality of life	10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by EQ-5D
Pulmonary function	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Spirometry and DLCO
Grip strength	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Measured by dynamometer
Patient reported impact of disease	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	RAID
Swollen joint count	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	44 joints
Tender joint count	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	28 joints
Erythrocyte sedimentation rate (ESR)	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Blood test
Presence of rheumatoid noduli	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Skin examination
Medication use	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Record of disease modifying drugs antirheumatic drugs including corticosteroids
Ultrasound inflammation	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Power doppler and B-mode
C-reactive protein (CRP)	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Blood test
Patient global assessment of disease activity	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity
Comorbidities	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Questionnaire
Interstitial lung disease	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by HRCT
Physical activity level	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by accelerometer
Patient reported Physical function	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Assessed by HAQ-PROMIS
Work Productivity	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)	Work Productivity and Activity Impairment Questionnaire: WPAI:RA

Trial Locations

Locations (11)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Vestre Viken Hospital; 🇳🇴 Drammen, Norway

Haugesund Hospital, Helse Fonna; 🇳🇴 Haugesund, Norway

Sørlandet Hospital; 🇳🇴 Kristiansand, Norway

Revmatolog Anne Lindtner Noraas; 🇳🇴 Kristiansand, Norway

Østfold Hospital; 🇳🇴 Moss, Norway

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St. Olavs hospital (Trondheim University hospital); 🇳🇴 Trondheim, Norway

Martina Hansens Hospital; 🇳🇴 Viken, Norway

Ålesund Hospital; 🇳🇴 Ålesund, Norway