About this trial
NOR-DMARD is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. Other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological DMARDs on work participation and work productivity, to investigate different strategies for use of biological DMARDs, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological DMARDs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, or any other inflammatory arthritis
Clinical indication to start a new treatment with a biological disease modifying anti-rheumatic drug or a kinase inhibitor
Disqualifiers
Unwillingness or unability to give written informed consent
Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol
Trial population
Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Secondary outcomes
Disease Activity Score-28 (DAS28)
American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70)
Simplified Disease Activity Index (SDAI)
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Diakonhjemmet Hospital
Lead sponsor
University Hospital of North Norway
Collaborator
St. Olavs Hospital
Collaborator
Lillehammer Hospital for Rheumatic Diseases
Collaborator
Vestre Viken Hospital Trust
Collaborator
Helse Forde
Collaborator