Clinical trial NCT03040583: The ASSESS National Multi-center Prospective Cohort
Official title: Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Sjögren's Syndrome
Keywords: Primary Sjögren's syndrome (PSS)
auto-immune diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Societe Francaise de Rhumatologie
First posted: 2017-02-02
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: expected population number is 395 patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From the beginning of the study until the end of the 20 years follow-up
measure: Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score
timeFrame: From the beginning of the study until the end of the 20 years follow-up
measure: number of patient developing a lymphoma
timeFrame: From the beginning of the study until the end of the 20 years follow-up
Secondary outcomes:
measure: number of patients with cancer
timeFrame: From the beginning of the study until the end of the 20 years follow-up
measure: number of patients with cardiovascular complication
timeFrame: From the beginning of the study until the end of the 20 years follow-up
measure: List of drugs taken by the patients
timeFrame: From the beginning of the study until the end of the 20 years follow-up
measure: Biological report (Blood test)
timeFrame: From the beginning of the study until the end of the 20 years follow-up
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: Hopital Bicêtre
state: Val De Marne
Study officials:
affiliation: SFR/AP-HP
name: Xavier Mariette
role: PRINCIPAL_INVESTIGATOR
References: