Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis (SEWORRA)

April 13, 2026 updated by: University Hospital, Rouen
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Department of Rheumatology, CHU de Caen
      • Caen, Le Havre, Rouen, Elbeuf, France
        • Normandy
      • Le Havre, France, 76290
        • Department of Rheumatology
      • Rouen, France, 76031
        • Department of Rheumatology
      • Saint-Aubin-lès-Elbeuf, France, 76410
        • Department of Rheumatology CHG Elbeuf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • failure to at least one TNF-blocking agent

Exclusion Criteria:

  • pregnant or childbearing woman
  • Rituximab contraindication
  • woman unable to use contraceptive means

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rituximab
Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
Drug: Rituximab
Device: ESAOTE MyLab60
US evaluation at different time points
Other Names:
  • sonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Olivier Vittecoq, MD,PHD, University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimated)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/081/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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