The ASSESS National Multi-center Prospective Cohort

NCT ID: NCT03040583

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 395 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2030-09-30

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.

Conditions

Primary Sjögren's Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ASSESS (PHRC) patients

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

No intervention

Intervention Type: OTHER

Patients data will be collected during their disease follow-up

Interventions

No intervention

Patients data will be collected during their disease follow-up

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societe Francaise de Rhumatologie

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Mariette

Role: PRINCIPAL_INVESTIGATOR

SFR/AP-HP

Locations

Hopital Bicêtre

Le Kremlin-Bicêtre, Val De Marne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Xavier Mariette

Role: CONTACT

xavier.mariette@aphp.fr

01.45.21.37.58

Jacques-Eric Gottenberg

Role: CONTACT

jacques-Eric.gottenberg@chru-strasbourg.fr

03.88.12.79.50

Facility Contacts

Xavier MARIETTE

Role: primary

xavier.mariette@aphp.fr

01.45.21.37.58

References

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.

Reference Type: DERIVED

PMID: 37115807 (View on PubMed)

Other Identifiers

P060228

Identifier Type: -

Identifier Source: org_study_id