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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

Tracking Information
First Submitted Date April 18, 2012
First Posted Date April 20, 2012
Last Update Posted Date August 23, 2022
Study Start Date April 2012
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 19, 2012)
  • Disease Activity Score-28 (DAS28) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Simplified Disease Activity Index (SDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Modified Health Assessment Questionnaire (MHAQ) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Rheumatoid Arthritis Impact of Disease (RAID) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • EuroQol 5-dimensions (EQ-5D) questionnaire [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
    Utility instrument
  • 28-Swollen joint count [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • 28-Tender joint count [ Time Frame: All follow-up visits ]
  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • C-Reactive Protein (CRP) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
  • Sharp/van der Heijde score [ Time Frame: 12, 24, 36, 48, 60 months ]
    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 ]
  • Clinical Disease Activity Index (CDAI) [ Time Frame: 3, 6, 9, 12, 18, 24, 36, 48, 60 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Norwegian Antirheumatic Drug Register
Official Title Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug
Condition Inflammatory Joint Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 19, 2012)
15000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2050
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eirik K Kristianslund, MD, PhD eirik.kristianslund@gmail.com
Contact: Espen A Haavardsholm, MD, PhD +4722454086 e.a.haavardsholm@medisin.uio.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01581294
Other Study ID Numbers DIA 2011-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Tore K Kvien, Diakonhjemmet Hospital
Original Responsible Party Same as current
Current Study Sponsor Diakonhjemmet Hospital
Original Study Sponsor Same as current
Collaborators
  • University Hospital of North Norway
  • St. Olavs Hospital
  • Lillehammer Hospital for Rheumatic Diseases
  • Vestre Viken Hospital Trust
  • Helse Forde
Investigators
Principal Investigator: Tore K Kvien, MD, PhD Diakonhjemmet Hospital
PRS Account Diakonhjemmet Hospital
Verification Date August 2022