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

January 14, 2010
December 8, 2011
April 2010
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01050010 on ClinicalTrials.gov Archive Site
Ultrasonography (hand, wrist and foot) [ Time Frame: at Month 0 (first vist) and Month 12 (last visit) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study
The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Rheumatoid Arthritis
Other: MRI
dedicated extremity MRI
Dedicated extremity MRI
Structural deterioration radiographic assessed by dedicated extremity MRI
Intervention: Other: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2012
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Christine ALBERT-SABONNADIERE, PhD albert-sabonnadiere.c@chu-nice.fr
France
 
NCT01050010
09-CIR-01
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Christine ALBERT-SABONNADIERE, PhD Nice University Hospital
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP