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

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ClinicalTrials.gov Identifier: NCT01050010
Recruitment Status : Unknown
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2010
Actual Primary Completion Date : April 2010
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Dedicated extremity MRI
Structural deterioration radiographic assessed by dedicated extremity MRI
Other: MRI
dedicated extremity MRI




Primary Outcome Measures :
  1. Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot) [ Time Frame: at Month 0 (first visit) and Month 12 (last visit) ]

Secondary Outcome Measures :
  1. Ultrasonography (hand, wrist and foot) [ Time Frame: at Month 0 (first vist) and Month 12 (last visit) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050010


Contacts
Contact: Christine ALBERT-SABONNADIERE, PhD albert-sabonnadiere.c@chu-nice.fr

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

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01050010     History of Changes
Other Study ID Numbers: 09-CIR-01
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011

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