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

Study Overview
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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.

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

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-term outcomes, Extra-articular manifestations