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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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16 December 2017 |
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Main ID: |
NCT02389283 |
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Date of registration:
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10/03/2015 |
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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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Reduced Ultrasound Counts in Rheumatoid Arthritis
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Scientific title:
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Sensitivity to Change of Different Reduced Ultrasound Counts in Rheumatoid Arthritis |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02389283 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Esperanza Naredo, PhD |
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Address:
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Telephone:
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Email:
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enaredo@ser.es |
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Affiliation:
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Name:
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ESPERANZA NAREDO, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital General Universitario Gregorio Marañón |
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Name:
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ESPERANZA NAREDO, PhD |
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Address:
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Telephone:
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Email:
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enaredo@ser.es |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of both genders, = 18 years of age
- Patients diagnosed with RA (according to the ACR 2010 criteria) with more than 6
months and less than 5 years of active evolution and DAS28 > 3.2 or SDAI > 11, which
start treatment with biologic DMARD for the first time, according to the product's
summary of products characteristics (SPC).
- Patients who have granted their written informed consent for the collection and review
of their data.
Exclusion Criteria:
- Patients who are already participating in a clinical trial/s at the moment of
participation in this study.
- Patients with rheumatic disease other than RA
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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Rheumatoid Arthritis
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Primary Outcome(s)
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Mode B and power Doppler (PD) ultrasound evaluation
[Time Frame: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD]
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Secondary Outcome(s)
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Dopler Ultrasound sensitivity to change comparison
[Time Frame: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD]
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Secondary ID(s)
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FIBHGM-EONC004-2014
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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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