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The Norwegian Antirheumatic Drug Register (NOR-DMARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01581294
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : August 23, 2022
Sponsor:
Collaborators:
University Hospital of North Norway
St. Olavs Hospital
Lillehammer Hospital for Rheumatic Diseases
Vestre Viken Hospital Trust
Helse Forde
Information provided by (Responsible Party):
Tore K Kvien, Diakonhjemmet Hospital

Study Description
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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.

Condition or disease
Inflammatory Joint Diseases

Detailed Description:
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, 12 months and every 12 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. Serious adverse events data will be systematically recorded, but other adverse events can also be retrieved by linkage to other registers.
Study Design
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Study Type : Observational
Estimated Enrollment : 15000 participants
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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2050
Estimated Study Completion Date : December 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Groups and Cohorts
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Outcome Measures
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Secondary Outcome Measures :
  1. Disease Activity Score-28 (DAS28) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  2. American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  3. Simplified Disease Activity Index (SDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  4. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  5. Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  6. Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  7. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  8. Modified Health Assessment Questionnaire (MHAQ) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  9. Rheumatoid Arthritis Impact of Disease (RAID) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  10. Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  11. EuroQol 5-dimensions (EQ-5D) questionnaire [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
    Utility instrument

  12. 28-Swollen joint count [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  13. 28-Tender joint count [ Time Frame: All follow-up visits ]
  14. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  15. C-Reactive Protein (CRP) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  16. Sharp/van der Heijde score [ Time Frame: 12, 24, 36, 48, 60 months ]
    Radiographic progression

  17. Number of participants with adverse events [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months ]
  18. Clinical Disease Activity Index (CDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]

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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581294


Contacts
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Contact: Eirik K Kristianslund, MD, PhD eirik.kristianslund@gmail.com
Contact: Espen A Haavardsholm, MD, PhD +4722454086 e.a.haavardsholm@medisin.uio.no

Locations
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Norway
Vestre Viken HF Drammen Hospital Completed
Drammen, Buskerud, Norway, 3004
Lillehammer Hospital for Rheumatic Diseases Recruiting
Lillehammer, Oppland, Norway, 2609
Contact: Yi Hu, MD PhD       Yi.Hu@revmatismesykehuset.no   
Principal Investigator: Yi Hu, MD PhD         
Førde Hospital Recruiting
Førde, Sogn Og Fjordane, Norway, 6807
Contact: Pawel F Mielnik, MD, PhD    +4757839000    pawel.franciszek.mielnik@helse-forde.no   
Principal Investigator: Pawel F Mielnik, MD, PhD         
St. Olavs Hospital Completed
Trondheim, Sør-Trøndelag, Norway, 7006
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: Eirik K Kristianslund, MD, PhD       eirik.kristianslund@gmail.com   
Contact: Espen A Haavardsholm, MD, PhD    +4722454086    e.a.haavardsholm@medisin.uio.no   
Principal Investigator: Tore K Kvien, MD, PhD         
Sub-Investigator: Eirik K Kristianslund, MD, PhD         
Sub-Investigator: Espen A Haavardsholm, MD, PhD         
Sponsors and Collaborators
Diakonhjemmet Hospital
University Hospital of North Norway
St. Olavs Hospital
Lillehammer Hospital for Rheumatic Diseases
Vestre Viken Hospital Trust
Helse Forde
Investigators
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Principal Investigator: Tore K Kvien, MD, PhD Diakonhjemmet Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tore K Kvien, Principal Investigator, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01581294    
Other Study ID Numbers: DIA 2011-1
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022
Keywords provided by Tore K Kvien, Diakonhjemmet Hospital:
Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis
Spondyloarthritis
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases