Inflammatory Myopathies in Primary Sjögren's Syndrome

• Conditions: Primary Sjögren Syndrome

• Registration Number: NCT03126383
• Lead Sponsor: University Hospital, Brest

Brief Summary

The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).

Detailed Description

Muscle disease is associated with pSS, but this association is not well defined. The AMISS study, a retrospective observational multicentric study, will recruit patients with pSS and muscle involvement in order to characterize in details the features of this association (epidemiological aspects, clinical presentation, biological, radiological and histological findings, treatments and outcomes).

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-24
• Last Update Posted: 2017-04-24
• Study Start: 2017-05-10
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diagnosis of Primary Sjögren's syndrome according to the ACR/EULAR classification criteria
• inflammatory muscle involvement, as diagnosed by the treating physician

Exclusion Criteria

• Diagnosis of inflammatory myopathy before the diagnosis of pSS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients fulfilling classification criteria for inflammatory myopathies	At diagnosis	Among the patients included in the AMISS study, we will assess the proportion of patients who fulfill the classification criteria for the different inflammatory myopathies.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France