The Norwegian Antirheumatic Drug Register
Recruiting · NCT01581294 · Observational (researchers observe without assigning treatment) · Lead sponsor: Diakonhjemmet Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
12 locations listed.
- Diakonhjemmet Hospital - Oslo, Norway
- Diakonhjemmet Hospital - Oslo, Norway
- Vestre Viken HF Drammen Hospital - Drammen, Buskerud, Norway
- Vestre Viken HF Drammen Hospital - Drammen, Buskerud, Norway
- Lillehammer Hospital for Rheumatic Diseases - Lillehammer, Oppland, Norway
- Lillehammer Hospital for Rheumatic Diseases - Lillehammer, Oppland, Norway
- Førde Hospital - Førde, Sogn Og Fjordane, Norway
- Førde Hospital - Førde, Sogn Og Fjordane, Norway
- St. Olavs Hospital - Trondheim, Sør-Trøndelag, Norway
- St. Olavs Hospital - Trondheim, Sør-Trøndelag, Norway
- University Hospital of Northern Norway - Tromsø, Troms, Norway
- University Hospital of Northern Norway - Tromsø, Troms, Norway