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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01050010
• Other study ID #: 09-CIR-01
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2010
• Last updated: December 8, 2011
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christine ALBERT-SABONNADIERE, PhD
• Email: albert-sabonnadiere.c[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Synovitis

Intervention

Other:
• MRI
dedicated extremity MRI

Locations

Country	Name	City	State
France	CHU de NICE	Nice
France	Rheumatology Department, Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)		at Month 0 (first visit) and Month 12 (last visit)	No
Secondary	Ultrasonography (hand, wrist and foot)		at Month 0 (first vist) and Month 12 (last visit)	No