NCT03040583

The ASSESS National Multi-center Prospective Cohort

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 395 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Sjögren's syndrome (pSS) affects 0,1% of the population. This systemic autoimmune disease is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. The previous or present systemic complications included skin, articular, lung, kidney, peripheral and central nervous system, muscular involvement and vasculitis, as well as lymphoma occurrence were recorded. For previous lymphoma, the diagnosis and the histological subtypes were confirmed by reanalysis of the medical and histological records. The objective of this cohort was to assess systemic complications (signs) and evolution of patients with pSS and to determine the evolution and factors predictors of lymphoma of systemic complications and lymphoma in pSS during a 20-years prospective follow-up. This cohort was successful in rheumatology field, 395 patients was recruited for 2 years in 15 French centers (10 rheumatology and internal medicine 5) and followed for 5 years until July 2014. The primary objective of this cohort is to assess the evolution of Primitive Sjogren Syndrome patients and to determine predictors factors of lymphoma and systemic complications during a 20-years prospective follow-up.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
OTHER	No intervention	Patients data will be collected during their disease follow-up

Timeline

• Start date: 2016-09-01
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2017-02-02
• Last updated: 2020-03-13

Locations

1 site across 1 country: France