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

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ClinicalTrials.gov Identifier: NCT01765374
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: ESAOTE MyLab60 Drug: Rituximab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
Study Start Date : February 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01765374     History of Changes
Other Study ID Numbers: 2010/081/HP
First Posted: January 10, 2013    Key Record Dates
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