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Status unknownNCT01050010Updated Dec 9, 2011

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

An interventional study of MRI in Rheumatoid Arthritis, sponsored by Centre Hospitalier Universitaire de Nice. Status unknown at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-09.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • rheumatoid arthritis
  • clinical remission
  • synovitis
  • dedicated extremity MRI
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Contra-indication to MRI
  • Pregnant or breast-feeding women
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Dedicated extremity MRI

    Structural deterioration radiographic assessed by dedicated extremity MRI

    Other: MRI

Interventions

  • OtherMRI

    dedicated extremity MRI

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Ultrasonography (hand, wrist and foot)

    Time frame: at Month 0 (first vist) and Month 12 (last visit)

06

Study locations

1 of 2 sites recruiting
  • CHU de NICE
    Nice, 06000, France
    • Christine ALBERT-SABONNADIERE, M.D. · Contact · 0492035481
    • Christine ALBERT-SABONNADIERE, M.D. · Principal investigator
    Recruiting
  • Rheumatology Department, Nice University Hospital
    Nice, 06000, France
    Not yet recruiting
07

Registry details

Key details

Study ID
NCT01050010
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jan 15, 2010
Start date
Apr 2010
Primary completion
Apr 2010
Completion
Apr 2012 (estimated)
Last update
Dec 9, 2011

Study contacts

Christine ALBERT-SABONNADIERE, PhD
Contact
albert-sabonnadiere.c@chu-nice.fr
Christine ALBERT-SABONNADIERE, PhD
principal investigator · Nice University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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