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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765374
First Posted: January 10, 2013
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765374


Locations
France
Normandy
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
Investigators
Principal Investigator: Olivier Vittecoq, MD,PHD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01765374     History of Changes
Other Study ID Numbers: 2010/081/HP
First Submitted: May 12, 2011
First Posted: January 10, 2013
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by University Hospital, Rouen:
rituximab
sonography
clinical response

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents