The Norwegian Antirheumatic Drug Register (NOR-DMARD)
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Purpose
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.
| Condition |
|---|
|
Inflammatory Joint Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study |
- Disease Activity Score-28 (DAS28) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Simplified Disease Activity Index (SDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Modified Health Assessment Questionnaire (MHAQ) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Rheumatoid Arthritis Impact of Disease (RAID) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- EuroQol 5-dimensions (EQ-5D) questionnaire [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]Utility instrument
- 28-Swollen joint count [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- 28-Tender joint count [ Time Frame: All follow-up visits ] [ Designated as safety issue: No ]
- Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- C-Reactive Protein (CRP) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
- Sharp/van der Heijde score [ Time Frame: 12, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]Radiographic progression
- Number of participants with adverse events [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months ] [ Designated as safety issue: Yes ]
- Clinical Disease Activity Index (CDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Samples (including serum, plasma and full blood) for biomarker or DNA/RNA discovery and validation will be collected and stored in a freezer at -70 C at visits at baseline and at the 3-month assessment.
| Estimated Enrollment: | 15000 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2050 |
| Estimated Primary Completion Date: | December 2050 (Final data collection date for primary outcome measure) |
This study is a modification, and an extension, of the NOR-DMARD study that was conducted in 5 Norwegian rheumatology departments in the period 2000-2012. The study includes a structured follow-up with study visits at baseline (start of biological drug) and after 3, 6, 9, 12 months and every 6 months thereafter. Each study visit includes clinical assessment, patient-reported outcomes and measurement of acute-phase reactants. The data collection also includes blood samples for biobank at baseline and 3 months, and annual radiographs of hands and feet in patients with peripheral arthritis. Adverse events data will be systematically recorded, but also retrieved by linkage to other registers.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug
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
Contacts and Locations| Contact: Elisabeth Lie, MD, PhD | +4722454825 | elisabeth_lie@yahoo.no |
| Contact: Espen A Haavardsholm, MD, PhD | +4722454086 | e.a.haavardsholm@medisin.uio.no |
| Norway | |
| Vestre Viken HF Drammen Hospital | Recruiting |
| Drammen, Buskerud, Norway, 3004 | |
| Contact: Cecilie Kaufmann, MD +4732803000 Cecilie.Sofie.Kaufmann@vestreviken.no | |
| Principal Investigator: Cecilie S Kaufmann, MD | |
| Lillehammer Hospital for Rheumatic Diseases | Recruiting |
| Lillehammer, Oppland, Norway, 2609 | |
| Contact: Knut Mikkelsen, MD +4761279500 knut.mikkelsen@revmatismesykehuset.no | |
| Principal Investigator: Knut Mikkelsen, MD | |
| St. Olavs Hospital | Recruiting |
| Trondheim, Sør-Trøndelag, Norway, 7006 | |
| Contact: Erik Rødevand, MD +4781555850 erik.rodevand@stolav.no | |
| Principal Investigator: Erik Rødevand, MD | |
| University Hospital of Northern Norway | Recruiting |
| Tromsø, Troms, Norway, 9038 | |
| Contact: Synøve Kalstad, MD +4791507766 Synove.Kalstad@unn.no | |
| Principal Investigator: Synøve Kalstad, MD | |
| Diakonhjemmet Hospital | Recruiting |
| Oslo, Norway, 0319 | |
| Contact: Elisabeth Lie, MD, PhD +4722454825 elisabeth_lie@yahoo.no | |
| Contact: Espen A Haavardsholm, MD, PhD +4722454086 e.a.haavardsholm@medisin.uio.no | |
| Principal Investigator: Tore K Kvien, MD, PhD | |
| Sub-Investigator: Elisabeth Lie, MD, PhD | |
| Sub-Investigator: Espen A Haavardsholm, MD, PhD | |
| Principal Investigator: | Tore K Kvien, MD, PhD | Diakonhjemmet Hospital |
More Information
No publications provided
| Responsible Party: | Tore K Kvien, Principal Investigator, Diakonhjemmet Hospital |
| ClinicalTrials.gov Identifier: | NCT01581294 History of Changes |
| Other Study ID Numbers: | DIA 2011-1 |
| Study First Received: | April 18, 2012 |
| Last Updated: | September 17, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Diakonhjemmet Hospital:
|
Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis Spondyloarthritis |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013