The ASSESS National Multi-center Prospective Cohort

  • End date
    Sep 24, 2030
  • participants needed
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 24 January 2021


The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjgren'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 Sjgren'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.


Primary Sjgren'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.

Condition Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome
Treatment No intervention
Clinical Study IdentifierNCT03040583
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

aged of 18 years or more
Primary Sjgren's Syndrome Patients who have already participated to the study ASSESS

Exclusion Criteria

secondary Sjgren's Syndrome (SJ) associated with other autoimmune diseases
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