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

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Vestre Viken HF Drammen Hospital
COMPLETED
Drammen
Førde Hospital
RECRUITING
Førde
Lillehammer Hospital for Rheumatic Diseases
RECRUITING
Lillehammer
Diakonhjemmet Hospital
RECRUITING
Oslo
University Hospital of Northern Norway
RECRUITING
Tromsø
St. Olavs Hospital
COMPLETED
Trondheim
Contact Information
Primary
Eirik K Kristianslund, MD, PhD
eirik.kristianslund@gmail.com
Backup
Espen A Haavardsholm, MD, PhD
e.a.haavardsholm@medisin.uio.no
+4722454086
Time Frame
Start Date: 2012-04
Estimated Completion Date: 2050-12
Participants
Target number of participants: 15000
Sponsors
Collaborators: University Hospital of North Norway, St. Olavs Hospital, Vestre Viken Hospital Trust, Helse Forde, Lillehammer Hospital for Rheumatic Diseases
Leads: Diakonhjemmet Hospital

This content was sourced from clinicaltrials.gov