The ASSESS National Multi-center Prospective Cohort

Recruiting

• Conditions: Primary Sjögren's Syndrome
• Interventions: Other: No intervention

• Registration Number: NCT03040583
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13
• Primary Completion: 2030-09
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASSESS (PHRC) patients	No intervention	Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS

Primary Outcome Measures

Name	Time	Method
Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score	From the beginning of the study until the end of the 20 years follow-up	To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications
number of patient developing a lymphoma	From the beginning of the study until the end of the 20 years follow-up	To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score	From the beginning of the study until the end of the 20 years follow-up

Secondary Outcome Measures

Name	Time	Method
Biological report (Blood test)	From the beginning of the study until the end of the 20 years follow-up	To Evaluate the role of biomarkers
number of patients with cancer	From the beginning of the study until the end of the 20 years follow-up	To analysis the incidence of cancer in patients with pSS.
number of patients with cardiovascular complication	From the beginning of the study until the end of the 20 years follow-up	To analysis the incidence of cardiovascular complications in patients with pSS.
List of drugs taken by the patients	From the beginning of the study until the end of the 20 years follow-up	To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)

Trial Locations

Locations (1)

Hopital Bicêtre; 🇫🇷 Le Kremlin Bicêtre, Val De Marne, France