The Norwegian Antirheumatic Drug Register (NOR-DMARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Diakonhjemmet Hospital
Sponsor:
Collaborators:
University Hospital of North Norway
St. Olavs Hospital
Lillehammer Hospital for Rheumatic Diseases
Vestre Viken HF Drammen Hospital
Information provided by (Responsible Party):
Tore K Kvien, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01581294
First received: April 18, 2012
Last updated: February 4, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Diakonhjemmet Hospital:

Secondary Outcome Measures:
  • 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)
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, 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581294

Contacts
Contact: Elisabeth Lie, MD, PhD +4722454825 elisabeth_lie@yahoo.no
Contact: Espen A Haavardsholm, MD, PhD +4722454086 e.a.haavardsholm@medisin.uio.no

Locations
Norway
Vestre Viken HF Drammen Hospital Recruiting
Drammen, Buskerud, Norway, 3004
Contact: Åse S Lexberg, MD    +4732803000    Ase.Stavland.Lexberg@vestreviken.no   
Principal Investigator: Åse S Lexberg, 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         
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 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         
Sponsors and Collaborators
Diakonhjemmet Hospital
University Hospital of North Norway
St. Olavs Hospital
Lillehammer Hospital for Rheumatic Diseases
Vestre Viken HF Drammen Hospital
Investigators
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: February 4, 2014
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 July 26, 2014