Clinical trial Recruiting at 4 sites Observational Ages 18 and up

Observational study on the effectiveness of biological treatments for inflammatory joint diseases

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

Run by Diakonhjemmet Hospital · NCT01581294 · Data updated 2026-11-12

This study is testing how well biological treatments work for people with inflammatory joint diseases like rheumatoid arthritis and psoriatic arthritis, while also looking at their safety over time.

More Inflammatory Joint Diseases trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment15000 (estimated)
SponsorDiakonhjemmet Hospital
Academic / other
Locations6 sites (Drammen, Buskerud and 5 other locations)
StatusRecruiting
StartedApril 2012
Main results expectedDecember 2050
Study endsDecember 2050
Registry record updatedAugust 23, 2022
Trial IDNCT01581294 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with a diagnosis of inflammatory arthritis who are starting a new treatment with biological DMARDs.

Probably not a fit

Patients with psychiatric disorders, substance abuse issues, or those participating in incompatible studies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study, known as NOR-DMARD, aims to evaluate the effectiveness and long-term safety of biological disease modifying anti-rheumatic drugs (DMARDs) in treating inflammatory joint diseases such as rheumatoid arthritis and psoriatic arthritis. It involves structured follow-up visits at baseline and at regular intervals to assess disease activity, health-related quality of life, and joint damage. The study also collects blood samples for biobanking and systematically records serious adverse events, while exploring predictors of treatment efficacy and cost-effectiveness. The data gathered will help improve treatment strategies and patient outcomes in clinical practice.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and better management of inflammatory joint diseases for patients.

How similar studies have gone: Previous studies on the effectiveness of biological DMARDs have shown promising results, indicating that this approach is supported by existing evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Lillehammer Hospital for Rheumatic Diseases
    Lillehammer, Oppland, Norway
    Recruiting
  • Førde Hospital
    Førde, Sogn Og Fjordane, Norway
    Recruiting
  • University Hospital of Northern Norway
    Tromsø, Troms, Norway
    Recruiting
  • Diakonhjemmet Hospital
    Oslo, Norway
    Recruiting
  • Vestre Viken HF Drammen Hospital
    Drammen, Buskerud, Norway
    Completed
  • St. Olavs Hospital
    Trondheim, Sør-Trøndelag, Norway
    Completed

Study contacts

  • Principal investigator: Tore K Kvien, MD, PhD — Diakonhjemmet Hospital
  • Study coordinator: Eirik K Kristianslund, MD, PhD
  • Email: eirik.kristianslund@gmail.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.