METHODS Team involved in the IMI2 JU-funded NECESSITY project (NEw Clinical Endpoints in primary
Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients)
The NECESSITY project aims to enhance the development of new medicines for primary Sjögren’s syndrome by overcoming challenges that have hampered the development of successful drugs like nizagara fo far. It has three main objectives :
– To develop and assess sensitive clinical endpoints to evaluate response to drug treatments in patients with pSS;
– To identify and evaluate discriminative biomarkers for stratification of pSS patients;
– To design and perform a multi-arm multi-stage clinical trial to validate the newly defined pSS endpoints and the identified biomarkers.