Rheumatoid Arthritis
Conditions
Keywords
Long-term outcomes, Extra-articular manifestations
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.
Interventions
None listed
Sponsors
Diakonhjemmet Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Assessed by the disease activity score (DAS) |
| Disease activity remission | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Remission based on 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Tender joints | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Assessed by Ritchie Articular index |
| Presence of rheumatoid noduli | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Skin examination |
| Osteoporosis | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Assessed by Dual-energy X-ray absorptiometry (DEXA) |
| 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 |
| Comorbidities | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Questionnaire |
| 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 |
| 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 |
| Health-related quality of life | 10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Assessed by EQ-5D |
| Work Productivity | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Work Productivity and Activity Impairment Questionnaire: WPAI:RA |
| Pulmonary function | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Spirometry and DLCO |
| 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 |
| C-reactive protein (CRP) | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Blood test |
| Erythrocyte sedimentation rate (ESR) | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Blood test |
| Ultrasound inflammation | At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study) | Power doppler and B-mode |
Countries
Norway
Outcome results
None listed