NCT03681964

Brief Summary

This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
54mo left

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress71%
Sep 2015Sep 2030

Study Start

First participant enrolled

September 28, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2030

Expected
Last Updated

September 24, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

September 21, 2018

Last Update Submit

September 21, 2018

Conditions

Primary Sjögren's Syndrome (pSS)

Outcome Measures

Primary Outcomes (1)

  • classification criteria

    classification criteria at inclusion of patients with suspected primary Sjögren's syndrome (pSS) underwent with standardised evaluation

    Inclusion (Day 0)

Eligibility Criteria

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

Patients with suspected pSS underwent a standardised evaluation

You may qualify if:

  • Patients with suspected pSS underwent a standardised evaluation

You may not qualify if:

  • Opposition of patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Study Officials

  • Valerie Devauchelle

    CHRU de Brest

    STUDY DIRECTOR

Central Study Contacts

Valerie Devauchelle, MD,PhD

CONTACT

33 (0) 2 98 34 72 64valerie.devauchelle-pensec@chu-brest.fr

Study Design

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

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 24, 2018

Study Start

September 28, 2015

Primary Completion

September 28, 2020

Study Completion (Estimated)

September 28, 2030

Last Updated

September 24, 2018

Record last verified: 2018-07

Locations

FR(1)