The Norwegian Antirheumatic Drug Register

Last updated: August 19, 2022
Sponsor: Diakonhjemmet Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01581294
DIA 2011-1
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Age >18 years
  • Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, orany other inflammatory arthritis
  • Clinical indication to start a new treatment with a biological disease modifyinganti-rheumatic drug or a kinase inhibitor

Exclusion

Exclusion Criteria:

  • Unwillingness or unability to give written informed consent
  • Psychiatric or mental disorders, alcohol abuse or other abuse of substances, languagebarriers or other factors which makes adherence to the study protocol impossible
  • Participation in blinded RCTs or other studies incompatible with the NOR-DMARD studyprotocol

Study Design

Total Participants: 15000
Study Start date:
April 01, 2012
Estimated Completion Date:
December 31, 2050

Study Description

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.

Connect with a study center

  • Vestre Viken HF Drammen Hospital

    Drammen, Buskerud 3004
    Norway

    Completed

  • Lillehammer Hospital for Rheumatic Diseases

    Lillehammer, Oppland 2609
    Norway

    Active - Recruiting

  • Førde Hospital

    Førde, Sogn Og Fjordane 6807
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, Sør-Trøndelag 7006
    Norway

    Completed

  • University Hospital of Northern Norway

    Tromsø, Troms 9038
    Norway

    Site Not Available

  • University Hospital of Northern Norway

    Tromsø, Troms 9038
    Norway

    Active - Recruiting

  • Diakonhjemmet Hospital

    Oslo, 0319
    Norway

    Active - Recruiting

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