The Norwegian Antirheumatic Drug Register

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDiakonhjemmet Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diakonhjemmet Hospital

Lead sponsor

University Hospital of North Norway

Collaborator

St. Olavs Hospital

Collaborator

Lillehammer Hospital for Rheumatic Diseases

Collaborator

Vestre Viken Hospital Trust

Collaborator

Helse Forde

Collaborator