The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study

NCT ID: NCT01050010

Last Updated: 2011-12-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.

Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.

Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.

To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.

On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.

In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid arthritis clinical remission synovitis dedicated extremity MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Dedicated extremity MRI

Structural deterioration radiographic assessed by dedicated extremity MRI

Group Type OTHER

MRI

Intervention Type OTHER

dedicated extremity MRI

Interventions

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MRI

dedicated extremity MRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Earlier rheumatoid arthritis (\<1 year)
* Clinical remission (DAS 28 \<2,6 ou SDAI \<5) since 6 months before the inclusion
* Unchanged DMARds and /or biologic therapy since 6 months before the inclusion
* Unchanged corticosteroid (5 mg/day) since 3 months before the inclusion in patients treated with this therapy
* No contre-indication to the MRI

Exclusion Criteria

* Contra-indication to MRI
* Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine ALBERT-SABONNADIERE, PhD

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital

Locations

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CHU de NICE

Nice, , France

Site Status RECRUITING

Rheumatology Department, Nice University Hospital

Nice, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Christine ALBERT-SABONNADIERE, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Christine ALBERT-SABONNADIERE, M.D.

Role: primary

Christine ALBERT-SABONNADIERE, PhD

Role: primary

Other Identifiers

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09-CIR-01

Identifier Type: -

Identifier Source: org_study_id