The Norwegian Antirheumatic Drug Register

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study

Conditions
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Inflammatory Joint Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score-28 (DAS28) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Simplified Disease Activity Index (SDAI) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Ankylosing Spondylitis Disease Activity Score (ASDAS) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Modified Health Assessment Questionnaire (MHAQ) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Rheumatoid Arthritis Impact of Disease (RAID) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Work Productivity and Activity Impairment (WPAI) Questionnaire |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| EuroQol 5-dimensions (EQ-5D) questionnaire | Utility instrument | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| 28-Swollen joint count |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| 28-Tender joint count |  | All follow-up visits | 
| Erythrocyte Sedimentation Rate (ESR) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| C-Reactive Protein (CRP) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 
| Sharp/van der Heijde score | Radiographic progression | 12, 24, 36, 48, 60 months | 
| Number of participants with adverse events |  | 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months | 
| Clinical Disease Activity Index (CDAI) |  | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Spondyloarthritis