The Norwegian Antirheumatic Drug Register

  • STATUS
    Recruiting
  • End date
    Dec 21, 2050
  • participants needed
    15000
  • sponsor
    Diakonhjemmet Hospital
Updated on 21 January 2021

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.

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, 9, 12 months and every 6 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, and annual radiographs of hands and feet in patients with peripheral arthritis. Adverse events data will be systematically recorded, but also retrieved by linkage to other registers.

Details
Condition Inflammatory Joint Diseases
Clinical Study IdentifierNCT01581294
SponsorDiakonhjemmet Hospital
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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