Observational study on the effectiveness of biological treatments for inflammatory joint diseases
Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diakonhjemmet Hospital Academic / other |
| Locations | 6 sites (Drammen, Buskerud and 5 other locations) |
| Trial ID | NCT01581294 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of inflammatory arthritis who are starting a new treatment with biological DMARDs.
Not a fit: Patients with psychiatric disorders, substance abuse issues, or those participating in incompatible studies may not benefit from this study.
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 performed: Previous studies on the effectiveness of biological DMARDs have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
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 this trial is running
Drammen, Buskerud and 5 other locations
- Vestre Viken HF Drammen Hospital — Drammen, Buskerud, Norway (Completed)
- Lillehammer Hospital for Rheumatic Diseases — Lillehammer, Oppland, Norway (Recruiting)
- Førde Hospital — Førde, Sogn Og Fjordane, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Sør-Trøndelag, Norway (Completed)
- University Hospital of Northern Norway — Tromsø, Troms, Norway (Recruiting)
- Diakonhjemmet Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Tore K Kvien, MD, PhD — Diakonhjemmet Hospital
- Study coordinator: Eirik K Kristianslund, MD, PhD
- Email: eirik.kristianslund@gmail.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.