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Inflammatory Joint DiseasesNOR-DMARDNCT01581294

The Norwegian Antirheumatic Drug Register

An observational study of Inflammatory Joint Diseases, run by Diakonhjemmet Hospital at 6 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Joint Diseases
How many people
15,000 participants
Where
6 sitesNorway
Study dates
Apr 2012to Dec 2050
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eirik K Kristianslund, MD, PhD contact

eirik.kristianslund@gmail.com

Espen A Haavardsholm, MD, PhD contact

+4722454086

e.a.haavardsholm@medisin.uio.no

6 sites in 1 country

Norway6 sites, 4 recruiting

  • Vestre Viken HF Drammen Hospital

    Drammen, Buskerud, 3004

    Completed

  • Førde Hospital

    Førde, Sogn Og Fjordane, 6807

    Pawel F Mielnik, MD, PhD, +4757839000, pawel.franciszek.mielnik@helse-forde.no

    Pawel F Mielnik, MD, PhD

    Recruiting

  • Lillehammer Hospital for Rheumatic Diseases

    Lillehammer, Oppland, 2609

    Yi Hu, MD PhD, Yi.Hu@revmatismesykehuset.no

    Yi Hu, MD PhD

    Recruiting

  • Diakonhjemmet Hospital

    Oslo, 0319

    Eirik K Kristianslund, MD, PhD, eirik.kristianslund@gmail.com

    Espen A Haavardsholm, MD, PhD, +4722454086, e.a.haavardsholm@medisin.uio.no

    Recruiting

  • University Hospital of Northern Norway

    Tromsø, Troms, 9038

    Synøve Kalstad, MD, +4791507766, Synove.Kalstad@unn.no

    Synøve Kalstad, MD

    Recruiting

  • St. Olavs Hospital

    Trondheim, Sør-Trøndelag, 7006

    Completed

Other trials in Norway

About this study

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

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.

Read the 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.

Keywords
Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Spondyloarthritis
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing, Spondylarthritis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2050 (estimated)
  4. Study completionDec 2050 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581294
Sponsor's protocol ID
DIA 2011-1
Acronym
NOR-DMARD
Status last verified
Aug 2022
First submitted
18 Apr 2012
Last updated
23 Aug 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Yoshida Y, Hammer HB, Sexton J, Nordberg L, Aga AB, Terslev L, Lillegraven S, Haarvardsholm EA. How to score the wrist joint by ultrasound: exploration of the most sensitive joint assessment during follow-up of early or established rheumatoid arthritis. Arthritis Res Ther. 2025 Oct 30;27(1):200. doi: 10.1186/s13075-025-03668-8.

    PubMed 41168848

  • 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.

    PubMed 32648248

  • Gehin 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.

    PubMed 31783773

  • Olsen 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.

    PubMed 30508189

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Joint Diseases, run by Diakonhjemmet Hospital at 6 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eirik K Kristianslund, MD, PhD (eirik.kristianslund@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01581294, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.

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