Clinical trial Recruiting at 1 site Observational Ages 18 and up

Long-term assessment of patients with Primary Sjögren's Syndrome

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

Run by Assistance Publique - Hôpitaux de Paris · NCT03040583 · Data updated 2026-11-12

This study is trying to understand how Primary Sjögren's Syndrome changes over time and what complications it might cause for patients over 20 years.

More Sjögren's Disease trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment395 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Le Kremlin-Bicêtre, Val De Marne)
StatusRecruiting
StartedSeptember 2016
Main results expectedSeptember 2030
Study endsSeptember 2030
Registry record updatedMarch 13, 2020
Trial IDNCT03040583 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 years or older who have been diagnosed with Primary Sjögren's Syndrome and have previously participated in the ASSESS study.

Probably not a fit

Patients with secondary Sjögren's Syndrome associated with other autoimmune diseases will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ASSESS national multi-center prospective cohort aims to evaluate the evolution and systemic complications of patients with Primary Sjögren's Syndrome (pSS) over a 20-year period. This observational study includes patients who meet the American-European Consensus Criteria for pSS and collects data on various systemic complications and predictors of lymphoma. Conducted across 15 centers in France, the study utilizes standardized case report forms filled out by clinicians annually. The cohort has previously followed 395 patients for 5 years, and the extension will continue to gather valuable insights into the disease's progression.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the long-term management and potential complications of Primary Sjögren's Syndrome, improving patient care.

How similar studies have gone: Previous cohorts in rheumatology have shown success in assessing similar conditions, indicating that this approach is both validated and valuable.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hopital Bicêtre
    Le Kremlin-Bicêtre, Val De Marne, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.