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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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19 February 2015 |
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Main ID: |
NCT01765374 |
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Date of registration:
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12/05/2011 |
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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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Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
SEWORRA |
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Scientific title:
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Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01765374 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Olivier Vittecoq, MD,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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Rouen University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- failure to at least one TNF-blocking agent
Exclusion Criteria:
- pregnant or childbearing woman
- Rituximab contraindication
- woman unable to use contraceptive means
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Rituximab
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Device: ESAOTE MyLab60
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Primary Outcome(s)
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global score of power-doppler activity measured by ultrasonography on 12 joints
[Time Frame: at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months)]
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Secondary ID(s)
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2010/081/HP
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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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