REgistry of Sjögren syndrome in Umcg - LongiTudinal (RESULT)

Recruiting

• Conditions: 10003816; no synonym exists; Sjögren's syndrome

• Registration Number: NL-OMON50565
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

• Confirmed diagnosis of pSS according to the AECG and/or ACR classification
criteria OR probable pSS, as defined by the following three criteria:
o The presence of at least 2 AECG criteria
o High clinical suspicion of pSS
o Absence of a more likely explanation of the complaints
• Age >= 18 years
• Written informed consent

Exclusion Criteria

• Presence of other systemic auto-immune diseases or IgG4 syndrome
• Subjects who are impaired or incapable of completing cohort-related
assessments
• Serious comorbidity or laboratory abnormalities that, in the opinion of the
investigator, unacceptably increase the burden or risk of participation in the
cohort.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease activity (ESSDAI) and disease damage (SSDDI).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical and patient-reported parameters, salivary and tear gland function,<br /><br>ultrasound and histopathology of salivary glands, laboratory parameters,<br /><br>immunological parameters in serum, saliva and tears, and genetic markers. </p><br>