Long-term assessment of patients with Primary Sjögren's Syndrome
Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 395 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Le Kremlin-Bicêtre, Val De Marne) |
| Trial ID | NCT03040583 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with secondary Sjögren's Syndrome associated with other autoimmune diseases will not benefit from this study.
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 performed: Previous cohorts in rheumatology have shown success in assessing similar conditions, indicating that this approach is both validated and valuable.
Eligibility criteria
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 this trial is running
Le Kremlin-Bicêtre, Val De Marne
- Hopital Bicêtre — Le Kremlin-Bicêtre, Val De Marne, France (Recruiting)
Study contacts
- Principal investigator: Xavier Mariette — Sfr/ap-Hp
- Study coordinator: Xavier Mariette
- Email: xavier.mariette@aphp.fr
- Phone: 01.45.21.37.58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.