Rheumatoid ArthritisPhase 4SEWORRANCT01765374
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
A Phase 4 study testing ESAOTE MyLab60 and Rituximab in people with Rheumatoid Arthritis, run by University Hospital, Rouen at 5 sites in France.
Trial summary
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ESAOTE MyLab60 and Rituximab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesFrance
- Study dates
- Feb 2011to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- failure to at least one TNF-blocking agent
Who cannot join
- pregnant or childbearing woman
- Rituximab contraindication
- woman unable to use contraceptive means
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Department of Rheumatology, CHU de Caen
Caen, 14033
Normandy
Caen, Le Havre, Rouen, Elbeuf
Department of Rheumatology
Le Havre, 76290
Department of rheumatology
Rouen, 76031
Department of Rheumatology CHG Elbeuf
Saint-Aubin-lès-Elbeuf, 76410
About this study
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ESAOTE MyLab60, Rituximab
- Keywords
- rituximab, sonography, clinical response
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESAOTE MyLab60Device
Also called sonography
US evaluation at different time points
RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| rituximab | Experimental | Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD) Receives: Device: ESAOTE MyLab60; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Vittecoq, MD,PHD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765374
- Sponsor's protocol ID
- 2010/081/HP
- Acronym
- SEWORRA
- Status last verified
- Apr 2026
- First submitted
- 12 May 2011
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36377584
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01765374
- Acronym / sponsor ID
- SEWORRA / 2010/081/HP
- Conditions
- Rheumatoid Arthritis
- Keywords
- rituximab, sonography, clinical response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab | Experimental | Device: ESAOTE MyLab60, Drug: RituximabOnly one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- failure to at least one TNF-blocking agent
Key exclusion criteria (3 listed)
- pregnant or childbearing woman
- Rituximab contraindication
- woman unable to use contraceptive means
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESAOTE MyLab60Also: sonographyUS evaluation at different time points | Device | rituximab |
| Rituximab | Drug | rituximab |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 36377584Vittecoq 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Vittecoq, MD,PHD principal investigator
University Hospital, Rouen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESAOTE MyLab60 and Rituximab in people with Rheumatoid Arthritis, run by University Hospital, Rouen at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.