The ASSESS National Multi-center Prospective Cohort

Primary Sjögren's Syndrome Clinical Trial

— ASSESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03040583
• Other study ID #: P060228
• Status: Recruiting
• Start date: September 2016
• Est. completion date: September 2030

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Xavier Mariette
• Phone: 01.45.21.37.58
• Email: xavier.mariette[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 395
• Est. completion date: September 2030
• Est. primary completion date: September 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• No intervention
Patients data will be collected during their disease follow-up

Locations

Country	Name	City	State
France	Hopital Bicêtre	Le Kremlin Bicêtre	Val De Marne

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Societe Francaise de Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications	From the beginning of the study until the end of the 20 years follow-up
Primary	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
Primary	number of patient developing a lymphoma	To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome	From the beginning of the study until the end of the 20 years follow-up
Secondary	number of patients with cancer	To analysis the incidence of cancer in patients with pSS.	From the beginning of the study until the end of the 20 years follow-up
Secondary	number of patients with cardiovascular complication	To analysis the incidence of cardiovascular complications in patients with pSS.	From the beginning of the study until the end of the 20 years follow-up
Secondary	List of drugs taken by the patients	To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)	From the beginning of the study until the end of the 20 years follow-up
Secondary	Biological report (Blood test)	To Evaluate the role of biomarkers	From the beginning of the study until the end of the 20 years follow-up