Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

NCT ID: NCT01765374

Last Updated: 2015-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rituximab

Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)

Group Type EXPERIMENTAL

ESAOTE MyLab60

Intervention Type DEVICE

US evaluation at different time points

Rituximab

Intervention Type DRUG

Interventions

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ESAOTE MyLab60

US evaluation at different time points

Intervention Type DEVICE

Rituximab

Intervention Type DRUG

Other Intervention Names

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sonography

Eligibility Criteria

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Inclusion Criteria

* failure to at least one TNF-blocking agent

Exclusion Criteria

* pregnant or childbearing woman
* Rituximab contraindication
* woman unable to use contraceptive means
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Vittecoq, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Department of Rheumatology, CHU de Caen

Caen, , France

Site Status

Normandy

Caen, Le Havre, Rouen, Elbeuf, , France

Site Status

Department of Rheumatology

Le Havre, , France

Site Status

Department of rheumatology

Rouen, , France

Site Status

Department of Rheumatology CHG Elbeuf

Saint-Aubin-lès-Elbeuf, , France

Site Status

Countries

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France

Other Identifiers

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2010/081/HP

Identifier Type: -

Identifier Source: org_study_id

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