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NCT04964661 Clinical Trial

Incidence of MRI Sacro-Iliac (SI) Joint Anomalies in Women With Spondyloarthritis (SpA)

Spondylarthritis Clinical Trial

— MISIA 2  

Official title:
Incidence of Sacro-iliac (SI) Joint Anomalies on MRI: Differentiation Criteria in Women With Spondyloarthritis (SpA

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04964661
Other study ID # RECHMPL20_0612
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date March 30, 2022

Study information
Verified date July 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 530
Est. completion date March 30, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion criteria: - Women aged 18 to 50 years old - SpA diagnosed - Pelvis MRI performed Exclusion criteria: - Pelvis MRI unavailable

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Medical Imaging
MRI imaging

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Rate of structural lesions of the sacroiliac joints structural lesions of the sacroiliac joints in the population of women affected by SpA day 1
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