Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— SEWORRA  

Official title:

Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765374
• Other study ID #: 2010/081/HP
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2011
• Last updated: January 21, 2015
• Start date: February 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• failure to at least one TNF-blocking agent

Exclusion Criteria:

• pregnant or childbearing woman

• Rituximab contraindication

• woman unable to use contraceptive means

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• ESAOTE MyLab60
US evaluation at different time points

Drug:
• Rituximab

Locations

Country	Name	City	State
France	Department of Rheumatology, CHU de Caen	Caen
France	Normandy	Caen, Le Havre, Rouen, Elbeuf
France	Department of Rheumatology	Le Havre
France	Department of rheumatology	Rouen
France	Department of Rheumatology CHG Elbeuf	Saint Aubin Les Elbeuf

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global score of power-doppler activity measured by ultrasonography on 12 joints	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	at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months)	No