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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01050010
First received: January 14, 2010
Last updated: December 8, 2011
Last verified: December 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 August 27, 2014