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NCT Number: NCT01581294

The Norwegian Antirheumatic Drug Register

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.

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Key information

Conditions

Inflammatory Joint Diseases Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestre Viken HF Drammen Hospital, Drammen, Buskerud, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Secondary outcomes

  1. Disease Activity Score-28 (DAS28)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  2. American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  3. Simplified Disease Activity Index (SDAI)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  4. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  5. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  6. Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  7. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  8. Modified Health Assessment Questionnaire (MHAQ)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  9. Rheumatoid Arthritis Impact of Disease (RAID)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  10. Work Productivity and Activity Impairment (WPAI) Questionnaire

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  11. EuroQol 5-dimensions (EQ-5D) questionnaire

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

    Utility instrument

  12. 28-Swollen joint count

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  13. 28-Tender joint count

    Time frame: All follow-up visits

  14. Erythrocyte Sedimentation Rate (ESR)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  15. C-Reactive Protein (CRP)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

  16. Sharp/van der Heijde score

    Time frame: 12, 24, 36, 48, 60 months

    Radiographic progression

  17. Number of participants with adverse events

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months

  18. Clinical Disease Activity Index (CDAI)

    Time frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Eirik K Kristianslund, MD, PhD

CONTACT

[email protected]

Espen A Haavardsholm, MD, PhD

CONTACT

[email protected]

+4722454086

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Helse Forde
  • Lillehammer Hospital for Rheumatic Diseases
  • St. Olavs Hospital
  • University Hospital of North Norway
  • Vestre Viken Hospital Trust

Registry information

Official study title

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

Acronym: NOR-DMARD

Important dates

Study start
2012
Primary completion
2050
Study completion
2050
First posted
Apr 20, 2012
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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