The Norwegian Antirheumatic Drug Register
NOR-DMARD
Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study
1 other identifier
observational
15,000
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2050
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2050
August 23, 2022
August 1, 2022
38.7 years
April 18, 2012
August 19, 2022
Conditions
Keywords
Outcome Measures
Secondary Outcomes (18)
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) remission
3, 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
- +13 more secondary outcomes
Eligibility Criteria
Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diakonhjemmet Hospitallead
- University Hospital of North Norwaycollaborator
- St. Olavs Hospitalcollaborator
- Lillehammer Hospital for Rheumatic Diseasescollaborator
- Vestre Viken Hospital Trustcollaborator
- Helse Fordecollaborator
Study Sites (6)
Vestre Viken HF Drammen Hospital
Drammen, Buskerud, 3004, Norway
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, 2609, Norway
Førde Hospital
Førde, Sogn Og Fjordane, 6807, Norway
St. Olavs Hospital
Trondheim, Sør-Trøndelag, 7006, Norway
University Hospital of Northern Norway
Tromsø, Troms, 9038, Norway
Diakonhjemmet Hospital
Oslo, 0319, Norway
Related Publications (3)
Mielnik P, Sexton J, Lie E, Bakland G, Loli LP, Kristianslund EK, Rodevand E, Lexberg AS, Kvien TK. Does Older Age have an Impact on Rituximab Efficacy and Safety? Results from the NOR-DMARD Register. Drugs Aging. 2020 Aug;37(8):617-626. doi: 10.1007/s40266-020-00782-x.
PMID: 32648248DERIVEDGehin JE, Goll GL, Warren DJ, Syversen SW, Sexton J, Strand EK, Kvien TK, Bolstad N, Lie E. Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study. Arthritis Res Ther. 2019 Nov 29;21(1):256. doi: 10.1186/s13075-019-2009-5.
PMID: 31783773DERIVEDOlsen IC, Lie E, Vasilescu R, Wallenstein G, Strengholt S, Kvien TK. Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry. Rheumatology (Oxford). 2019 Mar 1;58(3):481-491. doi: 10.1093/rheumatology/key338.
PMID: 30508189DERIVED
Biospecimen
Samples (including serum, plasma and full blood) for biomarker or DNA/RNA discovery and validation will be collected and stored in a freezer at -70 C at visits at baseline and at the 3-month assessment.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tore K Kvien, MD, PhD
Diakonhjemmet Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 18, 2012
First Posted
April 20, 2012
Study Start
April 1, 2012
Primary Completion (Estimated)
December 1, 2050
Study Completion (Estimated)
December 1, 2050
Last Updated
August 23, 2022
Record last verified: 2022-08