Inflammatory Myopathies in Primary Sjögren's Syndrome (AMISS)

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

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

Study Overview

• Status: Unknown
• Conditions: Primary Sjögren Syndrome

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Sjögren's syndrome

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2017
• Primary Completion (Anticipated): April 10, 2018
• Study Completion (Anticipated): April 10, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: AMISS (29BRC17.0031)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No