Skip to content

REgistry of Sjögren syndrome in Umcg - LongiTudinal (RESULT)

REgistry of Sjögren syndrome in Umcg - LongiTudinal (RESULT) - RESULT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50565
Enrollment
400
Registered
2015-02-26
Start date
2016-01-21
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

no synonym exists Sjögren's syndrome

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Disease activity (ESSDAI) and disease damage (SSDDI).

Secondary

MeasureTime frame
Clinical and patient-reported parameters, salivary and tear gland function, ultrasound and histopathology of salivary glands, laboratory parameters, immunological parameters in serum, saliva and tears, and genetic markers.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)