Inflammatory Joint Diseases Clinical Trial
— NOR-DMARDOfficial title:
Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study
| NCT number | NCT01581294 |
| Other study ID # | DIA 2011-1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2012 |
| Est. completion date | December 2050 |
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.
| Status | Recruiting |
| Enrollment | 15000 |
| Est. completion date | December 2050 |
| Est. primary completion date | December 2050 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Vestre Viken HF Drammen Hospital | Drammen | Buskerud |
| Norway | Førde Hospital | Førde | Sogn Og Fjordane |
| Norway | Lillehammer Hospital for Rheumatic Diseases | Lillehammer | Oppland |
| Norway | Diakonhjemmet Hospital | Oslo | |
| Norway | University Hospital of Northern Norway | Tromsø | Troms |
| Norway | St. Olavs Hospital | Trondheim | Sør-Trøndelag |
| Lead Sponsor | Collaborator |
|---|---|
| Diakonhjemmet Hospital | Helse Forde, Lillehammer Hospital for Rheumatic Diseases, St. Olavs Hospital, University Hospital of North Norway, Vestre Viken Hospital Trust |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Secondary | Disease Activity Score-28 (DAS28) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Simplified Disease Activity Index (SDAI) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Ankylosing Spondylitis Disease Activity Score (ASDAS) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Modified Health Assessment Questionnaire (MHAQ) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Rheumatoid Arthritis Impact of Disease (RAID) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Work Productivity and Activity Impairment (WPAI) Questionnaire | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | EuroQol 5-dimensions (EQ-5D) questionnaire | Utility instrument | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | |
| Secondary | 28-Swollen joint count | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | 28-Tender joint count | All follow-up visits | ||
| Secondary | Erythrocyte Sedimentation Rate (ESR) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | C-Reactive Protein (CRP) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months | ||
| Secondary | Sharp/van der Heijde score | Radiographic progression | 12, 24, 36, 48, 60 months | |
| Secondary | Number of participants with adverse events | 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months | ||
| Secondary | Clinical Disease Activity Index (CDAI) | 3, 6, 9, 12, 18, 24, 36, 48, 60 months |