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.
This study is a modification, and an extension, of the NOR-DMARD study that was conducted in 5 Norwegian rheumatology departments in the period 2000-2012. The study includes a structured follow-up with study visits at baseline (start of biological drug) and after 3, 6, 12 months and every 12 months thereafter. Each study visit includes clinical assessment, patient-reported outcomes and measurement of acute-phase reactants. The data collection also includes blood samples for biobank at baseline and 3 months. Serious adverse events data will be systematically recorded, but other adverse events can also be retrieved by linkage to other registers.
Study Type
OBSERVATIONAL
Enrollment
15,000
Vestre Viken HF Drammen Hospital
Drammen, Buskerud, Norway
COMPLETEDLillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, Norway
RECRUITINGFørde Hospital
Førde, Sogn Og Fjordane, Norway
RECRUITINGSt. Olavs Hospital
Trondheim, Sør-Trøndelag, Norway
COMPLETEDUniversity Hospital of Northern Norway
Tromsø, Troms, Norway
RECRUITINGDiakonhjemmet Hospital
Oslo, Norway
RECRUITINGDisease Activity Score-28 (DAS28)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Simplified Disease Activity Index (SDAI)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Modified Health Assessment Questionnaire (MHAQ)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
EuroQol 5-dimensions (EQ-5D) questionnaire
Utility instrument
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
28-Swollen joint count
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
28-Tender joint count
Time frame: All follow-up visits
Erythrocyte Sedimentation Rate (ESR)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
C-Reactive Protein (CRP)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
Sharp/van der Heijde score
Radiographic progression
Time frame: 12, 24, 36, 48, 60 months
Number of participants with adverse events
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months
Clinical Disease Activity Index (CDAI)
Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months
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