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Clinical Trials in France / NCT03040583
Recruiting Observational

The ASSESS National Multi-center Prospective Cohort

NCT03040583 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2016-09
Last updated
2020-03-13

Condition(s) studied

Primary Sjögren's Syndrome

Investigational drug(s) / intervention(s)

No intervention

No intervention: Patients data will be collected during their disease follow-up

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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
    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 — 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
    To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome

Trial sites (1)

FacilityCityRegionStatus
Hopital Bicêtre Le Kremlin-Bicêtre Val De Marne Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03040583 on ClinicalTrials.gov ↗ ← All trials in France