NECESSITY Project originates from the realization that clinical trial design in complex diseases such as primary Sjögren’s syndrome requires a personalised/stratified medicine approach alongside tailored outcome measures which are able to monitor systemic changes, functional readouts and patient perception.
NECESSITY Project aims to identify and validate new clinical end-points for primary Sjögren’s syndrome with the ambition to provide tailored outcome measures for use in future clinical trials (Objective 1).
NECESSITY Project aims to discover and validate discriminative biomarkers for stratification of primary Sjögren’s syndrome patients (Objective 2).
Finally, these new clinical end-points and biomarkers will be validated in an original multi-arms multi-stages clinical trial (Objective 3).