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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has not verified this record recently (last verified Dec 2011), so the status shown — last known as Recruiting — may be out of date.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

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's planned enrollment of 30 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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:

  • to MRI
  • Pregnant or breast-feeding women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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)

07

Study locations

1 of 2 sites recruiting
  • CHU de NICE
    Nice, 06000, France
    Recruiting
    • Christine ALBERT-SABONNADIERE, M.D. · Contact0492035481
    • Christine ALBERT-SABONNADIERE, M.D. · Principal investigator
  • Rheumatology Department, Nice University Hospital
    Nice, 06000, France
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01050010
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 ↗

Not currently enrolling

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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