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| Name | Class |
|---|---|
| Societe Francaise de Rhumatologie | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASSESS (PHRC) patients | Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Patients data will be collected during their disease follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| number of patients with cardiovascular complication |
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Inclusion Criteria:
Exclusion Criteria:
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expected population number is 395 patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier Mariette | Contact | 01.45.21.37.58 | xavier.mariette@aphp.fr | |
| Jacques-Eric Gottenberg | Contact | 03.88.12.79.50 | jacques-Eric.gottenberg@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier Mariette | SFR/AP-HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Bicêtre | Recruiting | Le Kremlin-Bicêtre | Val De Marne | 94270 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37115807 | Derived | Duret PM, Schleiss C, Kawka L, Meyer N, Ye T, Saraux A, Devauchelle-Pensec V, Seror R, Larroche C, Perdriger A, Sibilia J, Vallat L, Fornecker LM, Nocturne G, Mariette X, Gottenberg JE. Association Between Bruton's Tyrosine Kinase Gene Overexpression and Risk of Lymphoma in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2023 Oct;75(10):1798-1811. doi: 10.1002/art.42550. Epub 2023 Jul 28. |
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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 |
| 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 |
| 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 |