Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
SEWORRA
1 other identifier
interventional
30
1 country
5
Brief Summary
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 rheumatoid-arthritis
Started Feb 2011
Typical duration for phase_4 rheumatoid-arthritis
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 12, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 16, 2026
April 1, 2026
3.7 years
May 12, 2011
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
rituximab
EXPERIMENTALOnly one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
Interventions
Eligibility Criteria
You may qualify if:
- failure to at least one TNF-blocking agent
You may not qualify if:
- pregnant or childbearing woman
- Rituximab contraindication
- woman unable to use contraceptive means
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Department of Rheumatology, CHU de Caen
Caen, 14033, France
Normandy
Caen, Le Havre, Rouen, Elbeuf, France
Department of Rheumatology
Le Havre, 76290, France
Department of rheumatology
Rouen, 76031, France
Department of Rheumatology CHG Elbeuf
Saint-Aubin-lès-Elbeuf, 76410, France
Related Publications (1)
Vittecoq O, Kozyreff-Meurice M, Houivet E, Leon N, Berard L, Gauthier-Prieur M, Pouplin S, Avenel G, Brevet P, Benichou J, Michelin P, Marcelli C, Lequerre T. Clinical and ultrasonographic evaluation of the window of opportunity for retreatment with rituximab in rheumatoid arthritis patients from a multicentre real-life study. Clin Exp Rheumatol. 2023 May;41(5):1050-1058. doi: 10.55563/clinexprheumatol/zf8nnm. Epub 2022 Nov 12.
PMID: 36377584RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Vittecoq, MD,PHD
University Hospital, Rouen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2011
First Posted
January 10, 2013
Study Start
February 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 16, 2026
Record last verified: 2026-04