The ASSESS National Multi-center Prospective Cohort (ASSESS)

March 12, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

395

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Val De Marne
      • Le Kremlin Bicêtre, Val De Marne, France, 94270
        • Recruiting
        • Hôpital Bicêtre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

expected population number is 395 patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ASSESS (PHRC) patients
Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Other: No intervention
Patients data will be collected during their disease follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: From the beginning of the study until the end of the 20 years follow-up
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
Time Frame: From the beginning of the study until the end of the 20 years follow-up
From the beginning of the study until the end of the 20 years follow-up
number of patient developing a lymphoma
Time Frame: From the beginning of the study until the end of the 20 years follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with cancer
Time Frame: From the beginning of the study until the end of the 20 years follow-up
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
Time Frame: From the beginning of the study until the end of the 20 years follow-up
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
Time Frame: From the beginning of the study until the end of the 20 years follow-up
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)
Time Frame: From the beginning of the study until the end of the 20 years follow-up
To Evaluate the role of biomarkers
From the beginning of the study until the end of the 20 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Societe Francaise de Rhumatologie

Investigators

  • Principal Investigator: Xavier Mariette, SFR/AP-HP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2030

Study Completion (Anticipated)

September 1, 2030

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Sjögren's Syndrome

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe