Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis (SEWORRA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ESAOTE MyLab60
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rituximab, sonography, clinical response
Eligibility Criteria
Inclusion Criteria:
- failure to at least one TNF-blocking agent
Exclusion Criteria:
- pregnant or childbearing woman
- Rituximab contraindication
- woman unable to use contraceptive means
Sites / Locations
- Normandy
- Department of Rheumatology, CHU de Caen
- Department of Rheumatology
- Department of rheumatology
- Department of Rheumatology CHG Elbeuf
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rituximab
Arm Description
Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01765374
First Posted
May 12, 2011
Last Updated
January 21, 2015
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01765374
Brief Title
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
Acronym
SEWORRA
Official Title
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rituximab, sonography, clinical response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rituximab
Arm Type
Experimental
Arm Description
Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
Intervention Type
Device
Intervention Name(s)
ESAOTE MyLab60
Other Intervention Name(s)
sonography
Intervention Description
US evaluation at different time points
Intervention Type
Drug
Intervention Name(s)
Rituximab
Primary Outcome Measure Information:
Title
global score of power-doppler activity measured by ultrasonography on 12 joints
Description
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
Time Frame
at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
failure to at least one TNF-blocking agent
Exclusion Criteria:
pregnant or childbearing woman
Rituximab contraindication
woman unable to use contraceptive means
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Vittecoq, MD,PHD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Normandy
City
Caen, Le Havre, Rouen, Elbeuf
Country
France
Facility Name
Department of Rheumatology, CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Department of Rheumatology
City
Le Havre
ZIP/Postal Code
76290
Country
France
Facility Name
Department of rheumatology
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Department of Rheumatology CHG Elbeuf
City
Saint Aubin Les Elbeuf
ZIP/Postal Code
76410
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
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