Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
- Registration Number
- NCT01765374
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- failure to at least one TNF-blocking agent
Read More
Exclusion Criteria
- pregnant or childbearing woman
- Rituximab contraindication
- woman unable to use contraceptive means
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rituximab ESAOTE MyLab60 Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD) rituximab Rituximab Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
- Primary Outcome Measures
Name Time Method global score of power-doppler activity measured by ultrasonography on 12 joints at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Department of Rheumatology, CHU de Caen
🇫🇷Caen, France
Normandy
🇫🇷Caen, Le Havre, Rouen, Elbeuf, France
Department of rheumatology
🇫🇷Rouen, France
Department of Rheumatology
🇫🇷Le Havre, France
Department of Rheumatology CHG Elbeuf
🇫🇷Saint Aubin Les Elbeuf, France