NCT01432613

Brief Summary

Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The main aim of this interventional study is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2016

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.1 years

First QC Date

August 22, 2011

Last Update Submit

March 26, 2026

Conditions

MyositisPolymyositisDermatomyositisMyositis, Inclusion Body

Keywords

MyositisMagnetic Resonance ImagingMuscle biopsySensitivity and Specificity

Outcome Measures

Primary Outcomes (2)

  • Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI.

    Description : diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for the diagnostic of inflammatory myopathy.

    between Day 0 and 24 months

  • Presence of IIM diagnosed by muscle biopsy

    Presence of IIM according to ENMC histological criteria

    between Day 0 and 24 months

Secondary Outcomes (2)

  • Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation

    every 3 months (up to 24 months)

  • Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation

    every 3 months (up to 24 months)

Study Arms (1)

MRI-oriented muscle biopsy

OTHER

Muscle sample will be done following the usual care.

Procedure: MRI-oriented muscle biopsy

Interventions

MRI-oriented muscle biopsyPROCEDURE

Orientation of muscle biopsy according to the MRI results

MRI-oriented muscle biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Skin rash typical of dermatomyositis: "lilac" rash (+/- oedemata) of upper eyelids, periungual sign, erythematous-scaly eruption occurring over the MCP and IPP, elbow, knees (Gottron's signs ands papules), erythema of light-sensitive areas OR
  • Muscle weakness which is proximal, bilateral and objectifiable by clinical examination ≤ 4/5, and CPK≥2N (N\<170).
  • Increase CPK and presence of acquired myositis specific antibody
  • AND
  • Onset of troubles ≤3 years

You may not qualify if:

  • Pregnant female
  • Proximal motive neuropathy
  • Refusing participation
  • Patient under 18 years old
  • Adult patient under legal protection
  • Patient with contraindication for MRI, pacemaker
  • For all other magnetic or ironic implanted equipments, metal workers, must contact PI to ensure their eligibility
  • Ocular muscles weakness, isolated dysarthria,
  • Patients suffering from toxic myopathy, amyloidosis, inherited muscular dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Nord

Amiens, 80054, France

Location

MeSH Terms

Conditions

MyositisPolymyositisDermatomyositisMyositis, Inclusion BodyHypersensitivity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesImmune System Diseases

Study Officials

  • Yves ALLENBACH, MD, PhD

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

September 13, 2011

Study Start

December 22, 2010

Primary Completion

February 11, 2016

Study Completion

November 26, 2016

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)