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NCT01581294Recruiting

The Norwegian Antirheumatic Drug Register

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

Source: ClinicalTrials.gov · Last updated 23 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
15000 (estimated)
First submitted
18 Apr 2012
Start date
Apr 2012
Primary completion date
Dec 2050
Lead sponsor
Diakonhjemmet Hospital
NCT number
NCT01581294

What you commit to

  • Study type: Observational
  • Planned participants: 15000
  • From Apr 2012 to the primary completion date, Dec 2050
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible

Other

  • Unwillingness or unability to give written informed consent
  • Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vestre Viken HF Drammen Hospital
Coordinator of this site? Confirm its status
DrammenNorwayCompleted
Førde Hospital
Coordinator of this site? Confirm its status
FørdeNorwayRecruiting
Lillehammer Hospital for Rheumatic Diseases
Coordinator of this site? Confirm its status
LillehammerNorwayRecruiting
Diakonhjemmet Hospital
Coordinator of this site? Confirm its status
OsloNorwayRecruiting
University Hospital of Northern Norway
Coordinator of this site? Confirm its status
TromsøNorwayRecruiting
St Olavs Hospital
Coordinator of this site? Confirm its status
TrondheimNorwayCompleted

This page is information, not medical advice. Discuss any trial with your doctor.