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NCT03126383 Clinical Trial

Inflammatory Myopathies in Primary Sjögren's Syndrome

Primary Sjögren Syndrome Clinical Trial

— AMISS  

Official title:
Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03126383
Other study ID # AMISS (29BRC17.0031)
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 20, 2017
Last updated April 20, 2017
Start date May 10, 2017
Est. completion date April 10, 2018

Study information
Verified date April 2017
Source University Hospital, Brest
Contact Divi CORNEC
Phone 02-98-34-72-64
Email divi.cornec@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date April 10, 2018
Est. primary completion date April 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients fulfilling classification criteria for inflammatory myopathies 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. At diagnosis
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