Dietary Salt in Rheumatoid Arthritis
NCT03649178
Arthritis, Arthritis, Rheumatoid
Nashville, Tennessee, United States
View Trial DetailsNCT Number: NCT05304013
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.
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Notify Me18 year and older
All sexes
Observational
Haukeland University Hospital, Bergen, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Radiographs of hands and feet
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by the disease activity score (DAS)
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Remission based on disease activity score (DAS)
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by SF-36
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Power doppler and B-mode
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Measured by dynamometer
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
RAID
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
44 joints
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
28 joints
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by Ritchie Articular index
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Questionnaire
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Blood test
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Blood test
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Skin examination
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by Dual-energy X-ray absorptiometry (DEXA)
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Record of disease modifying drugs antirheumatic drugs including corticosteroids
Time frame: 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
Time frame: 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
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by HRCT
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by accelerometer
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by HAQ-PROMIS
Time frame: 10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by EQ-5D
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Work Productivity and Activity Impairment Questionnaire: WPAI:RA
Time frame: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Spirometry and DLCO
Diakonhjemmet Hospital
Other
Acronym: ARCTIC-FORWARD
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