Condition category
Musculoskeletal Diseases
Date applied
31/01/2011
Date assigned
07/04/2011
Last edited
17/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 January 2017

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tore Kristian Kvien

ORCID ID

Contact details

Department of Rheumatology
Diakonhjemmet Hospital
P.O. Box 23
Vinderen
Oslo
0319
Norway
-
t.k.kvien@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

NOR-VEAC

Study hypothesis

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

Regional Committee for Medical and Health Science Related Research Ethics South-East Region, 15/04/2010, ref: 2010/719

Study design

Longitudinal observational multicentre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

23/08/2010

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant 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.

Recruitment start date

23/08/2010

Recruitment end date

01/01/2017

Locations

Countries of recruitment

Norway

Trial participating centre

Diakonhjemmet Hospital
Oslo
0319
Norway

Sponsor information

Organisation

Diakonhjemmet Hospital (Norway)

Sponsor details

c/o Tore Kristian Kvien
Department of Rheumatology
P.O. Box 23
Vinderen
Oslo
0319
Norway
-
t.k.kvien@medisin.uio.no

Sponsor type

Hospital/treatment centre

Website

http://www.diakonsyk.no

Funders

Funder type

Industry

Funder name

Southern and Eastern Norway Regional Health Authority (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian Foundation for Health and Rehabilitation (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Abbott Norge AS (Norway) - unrestricted research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/03/2016: Plain English summary added.