The ASSESS National Multi-center Prospective Cohort
ConditionPrimary Sjögren's Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged of 18 years or more
Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Disqualifiers
secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases
Trial population
expected population number is 395 patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionPatients data will be collected during their disease follow-up
Treatment groups
395 Participants
are divided into 1 treatment groupGroup A: ASSESS (PHRC) patients1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From the beginning of the study until the end of the 20 years follow-up2
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-up3
number of patient developing a lymphoma
To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
Time frame
From the beginning of the study until the end of the 20 years follow-upSecondary outcomes
1
number of patients with cancer
To analysis the incidence of cancer in patients with pSS.
Time frame
From the beginning of the study until the end of the 20 years follow-up2
number of patients with cardiovascular complication
To analysis the incidence of cardiovascular complications in patients with pSS.
Time frame
From the beginning of the study until the end of the 20 years follow-up3
List of drugs taken by the patients
To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)
Time frame
From the beginning of the study until the end of the 20 years follow-up4
Biological report (Blood test)
To Evaluate the role of biomarkers
Time frame
From the beginning of the study until the end of the 20 years follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Societe Francaise de Rhumatologie
Collaborator
Source ClinicalTrials.gov