NCT04964661

Brief Summary

Retrospective study comparing the incidence of inflammatory and structural lesions seen on MRI of the sacro-iliac (SI) joints in a population of women affected by spondyloarthritis (SpA) and control women population (MISIA study NCT02956824). A previous study (MISIA) demonstrate SpA may be misdiagnosed on MRI in postpartum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics SpA. The primary objective of this study is to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints between SpA and control women, and determine differentiation criteria in SpA women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 6, 2021

Last Update Submit

July 19, 2021

Conditions

Spondylarthritis

Keywords

Diagnostic ImagingMagnetic Resonance ImagingSacroiliac Joint anomalies

Outcome Measures

Primary Outcomes (1)

  • Rate of MRI inflammatory of the sacroiliac joints

    MRI inflammatory of the sacroiliac joints in the population of women affected by SpA

    day 1

Secondary Outcomes (1)

  • Rate of structural lesions of the sacroiliac joints

    day 1

Study Arms (1)

SpA women MRI

Women affected by spondyloarthritis and performed a sacroiliac MRI

Other: Medical Imaging

Interventions

Medical ImagingOTHER

MRI imaging

SpA women MRI

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 to 50 years old Affected by spondyloarthritis Performed sacroiliac joint MRI

You may qualify if:

  • Women aged 18 to 50 years old
  • SpA diagnosed
  • Pelvis MRI performed

You may not qualify if:

  • \- Pelvis MRI unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Spondylarthritis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Catherine CYTEVAL, MD.PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 16, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 30, 2022

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

FR(1)