NCT03040583 The ASSESS National Multi-center Prospective Cohort
| NCT ID | NCT03040583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Primary Sjögren's Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 395 participants |
| Start Date | 2016-09 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 395 participants in total. It began in 2016-09 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Xavier Mariette
PRINCIPAL INVESTIGATOR
SFR/AP-HP
Frequently Asked Questions
Who can join the NCT03040583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Sjögren's Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03040583 currently recruiting?
Yes, NCT03040583 is actively recruiting participants. Contact the research team at xavier.mariette@aphp.fr for enrollment information.
Where is the NCT03040583 trial being conducted?
This trial is being conducted at Le Kremlin-Bicêtre, France.
Who is sponsoring the NCT03040583 clinical trial?
NCT03040583 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Xavier Mariette at SFR/AP-HP. The trial plans to enroll 395 participants.