NECESSITY – New clinical Endpoints in primary Sjӧgren’s Syndrome: an Interventional Trial based on stratifYing patients

Finanziato da H2020-Innovative Medicine Initiative 2_2017

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NECESSITY aims to identify and validate new clinical outcome assessments, and to discover and validate prognostic biomarkers, for use in future clinical trials of new drugs in development and to be submitted to regulatory authorities for market approval.
Develop and assess sensitive clinical endpoints, evaluate response to drug treatments in patients with primary Sjogren's Syndrome with high disease burden or systematic involvement. 
Risultati attesi
The ambition of the project is to fulfil the unmet need that is to identify new composite clinical end-points for pSS and to validate them.


  • Institut National De La Sante Et De La Recherche Medicale (Coordinator - France)
  • The University of Birmingham (UK)
  • Karolinska Institutet (Sweden)
  • University Of Newcastle Upon Tyne (UK)
  • Hopitaux Universitaires De Strasbourg (France)
  • Universitair Medisch Centrum Utrecht (Netherlands)
  • Universite De Bretagne Occidentale (France)
  • Fundacion Publica Andaluza Progreso Y Salud (Spain)
  • Ethniko Kai Kapodistriako Panepistimio Athinon (Greece)
  • Universite Paris Descartes (France)
  • Assistance Publique - Hopitaux De Paris (France)
  • Ecrin European Clinical Research Infrastructure Network (France)
  • Universitetet I Bergen (Norway)
  • Innovation Acta S.R.L (Italy)
  • Association Francaise Gougerot-Sjogren (France)
  • Queen Mary University of London (UK)
  • Universita Degli Studi Di Udine (Italy)
  • Institut Pasteur (France)
  • Helse Stavanger Hf (Norway)
  • Academisch Ziekenhuis Groningen (Netherlands)
  • Fundacio Clinic per a la Recerca Biomedica (Spain)
  • Novartis Pharma Ag (Switzerland)
  • Glaxosmithkline Research and Development Ltd (UK)
  • Bristol-Myers Squibb Company Corp (USA)
  • Institut De Recherches Internationales Servier (France)

Importo di progetto

Budget Uniud 100.000,00 €
Budget totale 8.200.000,00 €


  • Data avvio del progetto: 01/01/2019
  • Data fine del progetto: 31/12/2024