The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Apr 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedDecember 9, 2011
December 1, 2011
Same day
January 14, 2010
December 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
at Month 0 (first visit) and Month 12 (last visit)
Secondary Outcomes (1)
Ultrasonography (hand, wrist and foot)
at Month 0 (first vist) and Month 12 (last visit)
Study Arms (1)
Dedicated extremity MRI
OTHERStructural deterioration radiographic assessed by dedicated extremity MRI
Interventions
Eligibility Criteria
You may qualify if:
- Earlier rheumatoid arthritis (\<1 year)
- No contre-indication to the MRI
You may not qualify if:
- Contra-indication to MRI
- Pregnant or breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de NICE
Nice, 06000, France
Rheumatology Department, Nice University Hospital
Nice, 06000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine ALBERT-SABONNADIERE, PhD
Nice University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2010
First Posted
January 15, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2012
Last Updated
December 9, 2011
Record last verified: 2011-12