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The Norwegian Antirheumatic Drug Register

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01581294
Acronym
NOR-DMARD
Enrollment
15000
Registered
2012-04-20
Start date
2012-04-30
Completion date
2050-12-31
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Joint Diseases

Keywords

Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Spondyloarthritis

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

University Hospital of North Norway
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
Lillehammer Hospital for Rheumatic Diseases
CollaboratorOTHER
Vestre Viken Hospital Trust
CollaboratorOTHER
Helse Forde
CollaboratorOTHER
Diakonhjemmet Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Secondary

MeasureTime frameDescription
Disease Activity Score-28 (DAS28)3, 6, 9, 12, 18, 24, 36, 48, 60 months
American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Simplified Disease Activity Index (SDAI)3, 6, 9, 12, 18, 24, 36, 48, 60 months
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission3, 6, 9, 12, 18, 24, 36, 48, 60 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Modified Health Assessment Questionnaire (MHAQ)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Rheumatoid Arthritis Impact of Disease (RAID)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Work Productivity and Activity Impairment (WPAI) Questionnaire3, 6, 9, 12, 18, 24, 36, 48, 60 months
EuroQol 5-dimensions (EQ-5D) questionnaire3, 6, 9, 12, 18, 24, 36, 48, 60 monthsUtility instrument
28-Swollen joint count3, 6, 9, 12, 18, 24, 36, 48, 60 months
28-Tender joint countAll follow-up visits
Erythrocyte Sedimentation Rate (ESR)3, 6, 9, 12, 18, 24, 36, 48, 60 months
C-Reactive Protein (CRP)3, 6, 9, 12, 18, 24, 36, 48, 60 months
Sharp/van der Heijde score12, 24, 36, 48, 60 monthsRadiographic progression
Number of participants with adverse events3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months
Clinical Disease Activity Index (CDAI)3, 6, 9, 12, 18, 24, 36, 48, 60 months

Countries

Norway

Contacts

Primary ContactEirik K Kristianslund, MD, PhD
eirik.kristianslund@gmail.com
Backup ContactEspen A Haavardsholm, MD, PhD
e.a.haavardsholm@medisin.uio.no+4722454086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026