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The ASSESS National Multi-center Prospective Cohort (ASSESS)

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ClinicalTrials.gov Identifier: NCT03040583
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Societe Francaise de Rhumatologie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date January 13, 2017
First Posted Date February 2, 2017
Last Update Posted Date February 23, 2017
Study Start Date September 2016
Estimated Primary Completion Date September 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2017)
  • 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
  • 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 ]
  • 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
Original Primary Outcome Measures
 (submitted: January 31, 2017)
  • Number of patients with systemic complications and variation of complications during the follow-up assessed with 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
  • 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
Change History Complete list of historical versions of study NCT03040583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 20, 2017)
  • 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.
  • 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.
  • 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)
  • 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
Original Secondary Outcome Measures
 (submitted: January 31, 2017)
  • 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.
  • 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.
  • 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)
  • List of drugs taken by the patient & 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The ASSESS National Multi-center Prospective Cohort
Official Title Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population expected population number is 395 patients
Condition Primary Sjögren's Syndrome
Intervention Other: No intervention
Patients data will be collected during their disease follow-up
Study Groups/Cohorts ASSESS (PHRC) patients
Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 31, 2017)
395
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2030
Estimated Primary Completion Date September 2030   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xavier Mariette 01.45.21.37.58 xavier.mariette@aphp.fr
Contact: Jacques-Eric Gottenberg 03.88.12.79.50 jacques-Eric.gottenberg@chru-strasbourg.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03040583
Other Study ID Numbers P060228
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Societe Francaise de Rhumatologie
Investigators
Principal Investigator: Xavier Mariette SFR/AP-HP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2017