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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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1 March 2021 |
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Main ID: |
NCT04752748 |
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Date of registration:
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10/02/2021 |
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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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Power Doppler in Hand Joints of Early RA Patients
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Scientific title:
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Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04752748 |
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification
criteria;
- age between 18-65 years;
- female gender,
- naive for treatment.
Exclusion Criteria:
- use of oral > 10 mg/d glucocorticoid in the previous three weeks;
- serum aspartate aminotransferase or alanine aminotransferase level > 3 times the upper
limit of normal;
- bone marrow, auto-imune, lymphoproliferative or infectious diseases;
- pregnancy.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Early Rheumatoid Arthritis
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Intervention(s)
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Drug: Drug protocol
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Primary Outcome(s)
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Changes in Synovial blood flow (power doppler)
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Secondary Outcome(s)
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Changes in disease activity score
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Changes in Joint Damage
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Changes in Tenosynovitis
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Changes in erythrocyte sedimentation rate level (mm/hour)
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Changes in upper limb function
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Changes in C-reactive protein level (mg/liter)
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Change in Synovial Proliferation
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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Changes in function
[Time Frame: Baseline, after 4, 12, 24 and 48 weeks]
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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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