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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: May 12, 2011
Last updated: January 21, 2015
Last verified: January 2015
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.

Condition Intervention Phase
Rheumatoid Arthritis Device: ESAOTE MyLab60 Drug: Rituximab Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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

Enrollment: 30
Study Start Date: February 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rituximab
Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
Device: ESAOTE MyLab60
US evaluation at different time points
Other Name: sonography
Drug: Rituximab


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • failure to at least one TNF-blocking agent

Exclusion Criteria:

  • pregnant or childbearing woman
  • Rituximab contraindication
  • woman unable to use contraceptive means
  Contacts and Locations
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Please refer to this study by its identifier: NCT01765374

Caen, Le Havre, Rouen, Elbeuf, France
Department of Rheumatology, CHU de Caen
Caen, France, 14033
Department of Rheumatology
Le Havre, France, 76290
Department of rheumatology
Rouen, France, 76031
Department of Rheumatology CHG Elbeuf
Saint Aubin Les Elbeuf, France, 76410
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Olivier Vittecoq, MD,PHD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen Identifier: NCT01765374     History of Changes
Other Study ID Numbers: 2010/081/HP
Study First Received: May 12, 2011
Last Updated: January 21, 2015

Keywords provided by University Hospital, Rouen:
clinical response

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 21, 2017