Norwegian Very Early Arthritis Clinic (NOR-VEAC): spectrum of arthritides, disease course and predictors of outcomes
| ISRCTN | ISRCTN05526276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05526276 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2011
- Registration date
- 07/04/2011
- Last edited
- 24/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Arthritis is a common condition that causes joint pain and inflammation. This is an observational study following the disease course and treatment of four groups of patients who have been recently diagnosed with arthritis.
Who can participate?
Group 1: Patients aged 18 - 75 with arthritis in at least two joints of less than 16 weeks duration
Group 2: Patients aged 18 - 75 with rheumatoid arthritis of less than 12 months duration
Group 3: Patients aged 18 - 75 with any arthritis of less than 12 months duration who test positive for rheumatoid factor and anti-CCP (a blood test)
Group 4: Patients in group 2 and 3 who start treatment with a disease-modifying anti-rheumatic drug (DMARD)
What does the study involve?
At the start of the study all participants’ arthritis symptoms are assessed. Pain and fatigue, employment status, current treatment and changes in treatment are also recorded, and urine and blood samples are taken. Patients in group 1 have follow-up assessments at 3, 6, 9, 12, 18, 24 months, and then every 6 months up to 5 years. Follow-up assessments are stopped if the patient does not have any joint swelling on two consecutive visits. Patients in group 2 and 3 have follow-up assessments at 3, 6, 9, 12, 18, and 24 months, and then every 6 months up to 5 years. Patients in group 4 have monthly follow-up assessments until they have reached the treatment target (disappearance of symptoms [remission]) at two consecutive visits. They are then followed as group 2 and 3 up to 5 years. If the disease returns, follow-up is intensified with monthly assessments until the target has been reached again.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Diakonhjemmet Hospital (Norway)
When is the study starting and how long is it expected to run for?
August 2010 to December 2021
Who is funding the study?
1. Southern and Eastern Norway Regional Health Authority (Norway)
2. Norwegian Foundation for Health and Rehabilitation (Norway)
3. Abbott Norge AS (Norway)
Who is the main contact?
Prof Tore Kristian Kvien
t.k.kvien@medisin.uio.no
Contact information
Scientific
Department of Rheumatology
Diakonhjemmet Hospital
P.O. Box 23
Vinderen
Oslo
0319
Norway
| t.k.kvien@medisin.uio.no |
Study information
| Study design | Longitudinal observational multicentre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A longitudinal observational multicentre cohort study of the spectrum of arthritides, disease course and predictors of outcomes: The Norwegian Very Early Arthritis Clinic (NOR-VEAC) study |
| Study acronym | NOR-VEAC |
| Study objectives | Early identification of patients at risk of developing rheumatoid arthritis (RA) and treat-to-target strategy/tight control of treatment in patients not in remission has become the new paradigm in rheumatology. We aimed at applying these principles in patients with recent onset synovitis in the setting of a very early arthritis clinic. |
| Ethics approval(s) | Regional Committee for Medical and Health Science Related Research Ethics South-East Region, 15/04/2010, ref: 2010/719 |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis/undifferentiated arthritis |
| Intervention | Baseline: Data at baseline for all enrolled patients who sign informed consent: 1. Age 2. Gender 3. Years of education 4. Smoking (never, previous, current daily smoker) 5. Presumed diagnosis 6. Time of onset of first swollen joint 7. IgM rheumatoid factor (level) 8. Cyclic citrullinated peptide antibody (a-CCP) (level) 9. Erosive disease (yes/no) 10. Co-morbidity (checklist and questionnaire for cardiovascular disease) 11. Body mass index (BMI) Fulfillment of new and old RA criteria, as well as classification criteria for spondyloarthritis (ASAS) and psoriatic arthritis (CASPAR) will be recorded. Joint assessment (66 swollen, 28 tender) with calculated joint counts, pain and fatigue (100 mm VAS), patient global assessment (100 mm VAS), physician global assessment (100 mm VAS), HAQ, RAID, ESR, CRP, EQ-5D, employment status (work disability, indirect costs), current treatment and change in treatment. Serum, urine, and blood for biobank. Follow-up: Patients in group 1 will have follow-up examinations at 3, 6, 9, 12, 18, 24 months, and then every 6 months up to 5 years. Follow-up examinations will be terminated if the patient on two consecutive visits does not have any joint swelling. Patients in group 2 and 3 will have follow-up examinations at 3, 6, 9, 12, 18, and 24 months, and then every 6 months up to 5 years. Patients in group 4 (starting with DMARDs) will have monthly follow-up examinations until they have reached the predefined treatment target at two consecutive visits (remission, DAS28 less than 2.6). They will then be followed as group 2 and 3 up to 5 years. If a disease flare occurs (DAS28 greater than 2.6), the follow-up program will again be intensified with monthly examinations until the target again has been reached. The treatment program will be according to the new EULAR recommendations for use of synthetic and biological DMARDs. If DAS 28 is persistently elevated greater than 2.6 but driven by other factors than inflammation (eg tender joints), and the patient is in remission by clinical judgement (e.g. no swollen joints), less frequent assessments can be permitted. Assessments: The following assessments will be performed at the main visits (3, 6, 9, 12, 18, 24 months and then every 6 months up to 5 years): Joint assessment (66 swollen, 28 tender) with calculated joint counts, pain and fatigue (100 mm VAS), patient global assessment (100 mm VAS), physician global assessment (100 mm VAS), HAQ, RAID, ESR, CRP, EQ-5D, employment status (work disability, indirect costs), current treatment and change in treatment. At yearly visits, patients in group 1 will be reassessed for fulfillment of classification criteria (RA [2010 ACR/EULAR], SpA [ASAS], PsA [CASPAR]). The following assessments will be performed at the monthly visits between the main 3-month visits: Joint counts (28 joints), patient global VAS and ESR/CRP with calculation of DAS28. The following additional assessments will be performed at baseline and after 3, 6, and 12 months and then annually: Imaging (conventional radiographs hands and feet, MRI dominant hand (selected centers)) as well as serum and urine for research biobank. |
| Intervention type | Other |
| Primary outcome measure | Measured yearly throughout the study: 1. Development of rheumatoid arthritis or other specific inflammatory arthritic disease according to established classification criteria 2. Development of erosive arthritis |
| Secondary outcome measures | Measured at study end: 1. Achievement of stable remission of disease activity 2. Health status 3. Quality of life/utility 4. Indirect costs |
| Overall study start date | 23/08/2010 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Key inclusion criteria | Group 1: 1. Patients of both genders 2. Aged 18 - 75 years 3. Patients with arthritis in at least 2 peripheral joints of less than 16 weeks duration (onset of arthritis is defined as the time when at least one joint became swollen) Group 2: 1. Patients of both genders 2. Aged 18 - 75 years with RA according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria 3. Patients with arthritis of less than 12 months duration (onset of arthritis is defined as the time when at least one joint became swollen) Group 3: Patients of both genders aged 18 - 75 years with any arthritis (including monoarthritis) of less than 12 months duration with presence of positive anti-CCP and/or rheumatoid factor. Onset of arthritis is defined as the time when at least one joint became swollen. Group 4: Patients in group 2 and 3 who start treatment with a disease modifying anti-rheumatic drug (DMARD) |
| Key exclusion criteria | Patients with the following reasons for joint swelling will be excluded from follow-up: 1. Osteoarthritis 2. Trauma 3. Mechanical joint lesion (e.g. meniscus lesion) 4. Gout 5. Pseudogout 6. Septic arthritis 7. Acute sarcoid arthropathy If any of these conditions are diagnosed during the course of the study, patients will be excluded from further follow-up. |
| Date of first enrolment | 23/08/2010 |
| Date of final enrolment | 01/03/2016 |
Locations
Countries of recruitment
- Norway
Study participating centre
0319
Norway
Sponsor information
Hospital/treatment centre
c/o Tore Kristian Kvien
Department of Rheumatology
P.O. Box 23
Vinderen
Oslo
0319
Norway
| t.k.kvien@medisin.uio.no | |
| Website | http://www.diakonsyk.no |
"ROR" |
https://ror.org/02jvh3a15 |
Funders
Funder type
Industry
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of interim results in a high impact peer reviewed journal by 01/06/2018. Planned publication of final results in a high impact peer reviewed journal by 01/01/2023. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
24/01/2018: The recruitment end date was changed from 01/01/2017 to 01/03/2016. Publication plan, intention to publish date and participant level data was added.
15/01/2018: The overall trial end date was changed from 01/01/2017 to 31/12/2021.
17/03/2016: Plain English summary added.
