The ASSESS National Multi-center Prospective Cohort

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

Sponsoren

Hauptsponsor: Assistance Publique - Hôpitaux de Paris

Mitarbeiter: Societe Francaise de Rhumatologie

Quelle Assistance Publique - Hôpitaux de Paris
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Recruiting
Anfangsdatum September 2016
Fertigstellungstermin September 2030
Primäres Abschlussdatum September 2030
Studientyp Observational [Patient Registry]
Primärer Ausgang
Messen Zeitfenster
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
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 From the beginning of the study until the end of the 20 years follow-up
Sekundäres Ergebnis
Messen Zeitfenster
number of patients with cancer From the beginning of the study until the end of the 20 years follow-up
number of patients with cardiovascular complication From the beginning of the study until the end of the 20 years follow-up
List of drugs taken by the patients From the beginning of the study until the end of the 20 years follow-up
Biological report (Blood test) From the beginning of the study until the end of the 20 years follow-up
Einschreibung 395
Bedingung
Intervention

Interventionsart: Other

Interventionsname: No intervention

Beschreibung: Patients data will be collected during their disease follow-up

Armgruppenetikett: ASSESS (PHRC) patients

Teilnahmeberechtigung

Probenahmeverfahren: Probability Sample

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Xavier Mariette Principal Investigator SFR/AP-HP
Gesamtkontakt

Nachname: Xavier Mariette

Telefon: 01.45.21.37.58

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Hopital Bicêtre Xavier MARIETTE 01.45.21.37.58 [email protected]
Standort Länder

France

Überprüfungsdatum

March 2020

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: ASSESS (PHRC) patients

Beschreibung: Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS

Akronym ASSESS
Patientendaten No
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Prospective

Quelle: ClinicalTrials.gov