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

This study is currently recruiting participants.

Verified December 2011 by Centre Hospitalier Universitaire de Nice

First Received on January 14, 2010. Last Updated on December 8, 2011 History of Changes

Sponsor:	Centre Hospitalier Universitaire de Nice
Information provided by (Responsible Party):	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01050010

Purpose

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.

Condition	Intervention
Rheumatoid Arthritis	Other: MRI

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Rheumatoid Arthritis Ultrasound

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot) [ Time Frame: at Month 0 (first visit) and Month 12 (last visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ultrasonography (hand, wrist and foot) [ Time Frame: at Month 0 (first vist) and Month 12 (last visit) ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2010
Estimated Study Completion Date:	April 2012
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dedicated extremity MRI Structural deterioration radiographic assessed by dedicated extremity MRI	Other: MRI dedicated extremity MRI

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050010

Contacts

Contact: Christine ALBERT-SABONNADIERE, PhD

albert-sabonnadiere.c@chu-nice.fr

Locations

France
Rheumatology Department, Nice University Hospital	Not yet recruiting
Nice, France, 06000
Contact: Christine ALBERT-SABONNADIERE, PhD albert-sabonnadiere.c@chu-nice.fr
CHU de NICE	Recruiting
Nice, France, 06000
Contact: Christine ALBERT-SABONNADIERE, M.D. 0492035481
Principal Investigator: Christine ALBERT-SABONNADIERE, M.D.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator:

Christine ALBERT-SABONNADIERE, PhD

Nice University Hospital

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01050010 History of Changes
Other Study ID Numbers:	09-CIR-01
Study First Received:	January 14, 2010
Last Updated:	December 8, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency France: French Data Protection Authority France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:

rheumatoid arthritis
clinical remission
synovitis
dedicated extremity MRI

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Synovitis
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 24, 2012