NCT01581294 The Norwegian Antirheumatic Drug Register
| NCT ID | NCT01581294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diakonhjemmet Hospital |
| Condition | Inflammatory Joint Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 15,000 participants |
| Start Date | 2012-04 |
| Primary Completion | 2050-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15,000 participants in total. It began in 2012-04 with a primary completion date of 2050-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Eirik K Kristianslund, MD, PhD
✉ eirik.kristianslund@gmail.comTore K Kvien, MD, PhD
PRINCIPAL INVESTIGATOR
Diakonhjemmet Hospital
Frequently Asked Questions
Who can join the NCT01581294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Joint Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01581294 currently recruiting?
Yes, NCT01581294 is actively recruiting participants. Contact the research team at eirik.kristianslund@gmail.com for enrollment information.
Where is the NCT01581294 trial being conducted?
This trial is being conducted at Drammen, Norway, Lillehammer, Norway, Førde, Norway, Trondheim, Norway and 2 additional locations.
Who is sponsoring the NCT01581294 clinical trial?
NCT01581294 is sponsored by Diakonhjemmet Hospital. The principal investigator is Tore K Kvien, MD, PhD at Diakonhjemmet Hospital. The trial plans to enroll 15,000 participants.