NCT03126383

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

April 20, 2017

Last Update Submit

April 20, 2017

Conditions

Primary Sjögren Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Sjögren's syndrome

You may qualify if:

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

You may not qualify if:

  • Diagnosis of inflammatory myopathy before the diagnosis of pSS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Central Study Contacts

Divi CORNEC

CONTACT

02-98-34-72-64divi.cornec@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 24, 2017

Study Start

May 10, 2017

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

FR(1)