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Inflammatory Myopathies in Primary Sjögren's Syndrome (AMISS)

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ClinicalTrials.gov Identifier: NCT03126383
Recruitment Status : Unknown
Verified April 2017 by University Hospital, Brest.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome
Estimated Study Start Date : May 10, 2017
Estimated Primary Completion Date : April 10, 2018
Estimated Study Completion Date : April 10, 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients fulfilling classification criteria for inflammatory myopathies [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Sjögren's syndrome
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126383


Contacts
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Contact: Divi CORNEC 02-98-34-72-64 divi.cornec@chu-brest.fr

Locations
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France
CHRU de Brest Not yet recruiting
Brest, France, 29609
Contact: Divi CORNC       divi.cornec@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03126383     History of Changes
Other Study ID Numbers: AMISS (29BRC17.0031)
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases