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Taking people in NorwayNo phase

Tracks long-term treatment of inflammatory joint diseases with biologic drugs

Follows adults with inflammatory joint disease who take biologic disease-modifying drugs.

Plain-language title generated from the registry record
Registry title: The Norwegian Antirheumatic Drug Register

Key facts

Where
Drammen, Førde, Lillehammer, Oslo, Tromsø, and Trondheim, NorwaySee the 6 sites

Where in Norway

  • Vestre Viken HF Drammen HospitalDrammen, NorwayNo longer taking part
  • Førde HospitalFørde, NorwayTaking people
  • Lillehammer Hospital for Rheumatic DiseasesLillehammer, NorwayTaking people
  • Diakonhjemmet HospitalOslo, NorwayTaking people
  • University Hospital of Northern NorwayTromsø, NorwayTaking people
  • St Olavs HospitalTrondheim, NorwayNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Diakonhjemmet Hospital
Trial code
NCT01581294
Record updated
23 August 2022
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible; Unwillingness or unability to give written informed consent; Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol.

ClinicalTrials.gov NCT01581294