Rheumatoid Arthritis Clinical Trial
— SEWORRAOfficial title:
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
Verified date | January 2015 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - failure to at least one TNF-blocking agent Exclusion Criteria: - pregnant or childbearing woman - Rituximab contraindication - woman unable to use contraceptive means |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Department of Rheumatology, CHU de Caen | Caen | |
France | Normandy | Caen, Le Havre, Rouen, Elbeuf | |
France | Department of Rheumatology | Le Havre | |
France | Department of rheumatology | Rouen | |
France | Department of Rheumatology CHG Elbeuf | Saint Aubin Les Elbeuf |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | global score of power-doppler activity measured by ultrasonography on 12 joints | Each time point will be assessed since the main objective of the study is to detect the time of sonographic relapse prior to clinical relapse | at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months) | No |
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