The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional screening trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, clinical remission, synovitis, dedicated extremity MRI
Eligibility 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
Sites / Locations
- CHU de NICERecruiting
- Rheumatology Department, Nice University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dedicated extremity MRI
Arm Description
Structural deterioration radiographic assessed by dedicated extremity MRI
Outcomes
Primary Outcome Measures
Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
Secondary Outcome Measures
Ultrasonography (hand, wrist and foot)
Full Information
NCT ID
NCT01050010
First Posted
January 14, 2010
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01050010
Brief Title
The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study
Official Title
The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, clinical remission, synovitis, dedicated extremity MRI
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dedicated extremity MRI
Arm Type
Other
Arm Description
Structural deterioration radiographic assessed by dedicated extremity MRI
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
dedicated extremity MRI
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Ultrasonography (hand, wrist and foot)
Time Frame
at Month 0 (first vist) and Month 12 (last visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine ALBERT-SABONNADIERE, PhD
Email
albert-sabonnadiere.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine ALBERT-SABONNADIERE, PhD
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de NICE
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine ALBERT-SABONNADIERE, M.D.
Phone
0492035481
First Name & Middle Initial & Last Name & Degree
Christine ALBERT-SABONNADIERE, M.D.
Facility Name
Rheumatology Department, Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine ALBERT-SABONNADIERE, PhD
Email
albert-sabonnadiere.c@chu-nice.fr
12. IPD Sharing Statement
Learn more about this trial
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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