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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
NCT03214263 |
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Date of registration:
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06/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases
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Scientific title:
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Identification of New Biomarkers to Improve Diagnostics or Predict Treatment Responses, Adverse Events or Prognosis in Patients With Inflammatory Rheumatic Disease Followed in the Danish Nationwide Quality Registry, DANBIO |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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20000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03214263 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Merete L Hetland, Professor, MD, DMSc, PhD |
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Address:
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Telephone:
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0045-38633330 |
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Email:
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merete.hetland@dadlnet.dk |
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Affiliation:
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Name:
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Merete L Hetland, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Glostrup, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with or suspected for the following diseases: rheumatoid arthritis (RA),
psoriatic arthritis (PsA), axial spondyloarthritis (axSpA) or other inflammatory
rheumatic diseases, connective tissue disorders or gout
- Aged 18 year or older
- Able to give informed consent
Exclusion Criteria:
- None
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Axial Spondyloarthritis
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Gout
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Psoriatic Arthritis
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Connective Tissue Diseases
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Primary Outcome(s)
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To predict treatment effectiveness and tolerability for the individual patient
[Time Frame: At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months]
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To diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity
[Time Frame: Changes from baseline to 3, 6, 12, 24, 36, 48, and 60 months]
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To improve prognostication
[Time Frame: At diagnosis and after 3, 6, 12, 24, 36, 48 and 60 months]
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Secondary ID(s)
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REUM BIOMARKØRER 2014-10-30
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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