RecruitingNCT03040583

The ASSESS National Multi-center Prospective Cohort

Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

395 participants

Start Date

Sep 1, 2016

Study Type

OBSERVATIONAL

Conditions

Primary Sjögren's Syndrome

Summary

The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome "pSS" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The ASSESS cohort is a 20-year French follow-up study of patients with primary Sjögren's syndrome (pSS) — a chronic autoimmune disease that causes severe dry eyes and mouth, fatigue, and pain, and can affect multiple organ systems. Originally launched in 2006 across 15 French centers, the study tracks disease progression, systemic complications (such as lung, kidney, and nervous system involvement), and the development of lymphoma over time to identify which patients are at highest risk. Eligible participants are adults aged 18 or older who already participated in the original ASSESS study with a confirmed diagnosis of primary Sjögren's syndrome (not secondary to another autoimmune disease). Annual follow-up assessments use standardized clinical forms to document new developments in disease activity and complications. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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