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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01765374
First received: May 12, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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:

Drug Information available for: Rituximab
U.S. FDA Resources

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


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765374

Contacts
Contact: Olivier Vittecoq, MD,PHD +33 2 32 88 90 19 olivier.vittecoq@chu-rouen.fr

Locations
France
Department of Rheumatology, CHU de Caen Recruiting
Caen, France, 14033
Contact: Christian Marcelli, MD     33 2 31 06 31 06     marcelli-c@chu-caen.fr    
Normandy Enrolling by invitation
Caen, Le Havre, Rouen, Elbeuf, France
Department of Rheumatology Recruiting
Le Havre, France, 76290
Contact: Charles Zarnitsky     33 2 32 73 32 32     czarnitsky@ch-havre.fr    
Department of rheumatology Recruiting
Rouen, France, 76031
Contact: Olivier Vittecoq, MD,PhD     33 2 32 88 90 19     olivier.vittecoq@chu-rouen.fr    
Department of Rheumatology CHG Elbeuf Recruiting
Saint Aubin Les Elbeuf, France, 76410
Contact: Frenando da Silva, MD     33 2 32 96 35 35     fernando.dasilva@chi-elbeuf-louviers.fr    
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

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 9, 2013
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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013