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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01765374
First received: May 12, 2011
Last updated: January 21, 2015
Last verified: January 2015
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765374

Locations
France
Department of Rheumatology, CHU de Caen
Caen, France, 14033
Normandy
Caen, Le Havre, Rouen, Elbeuf, France
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 
Study First Received: May 12, 2011
Last Updated: January 21, 2015
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 21, 2016