NECESSITY - NEw Clinical Endpoints in primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients

logo necessity.pngTitolo progetto: NECESSITY - NEw Clinical Endpoints in primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients

Programma di finanziamento: Horizon 2020 – Innovative Medicine Initiative 2

Responsabile scientifico: prof. Salvatore De Vita

Collaboratori: prof. Luca Quartuccio, dott.ssa Saviana Gandolfo

Ruolo del DAME: partner

Descrizione generale:

Primary Sjögren’s Syndrome (pSS) is an autoimmune disease in which the immune system attacks cells in the body that secrete fluids, such as tear ducts and salivary glands. Symptoms include itchy eyes, a dry mouth, joint and muscle pain, difficulty concentrating, and disabling fatigue. Around a third of patients also experience other health problems such as arthritis, fever, vasculitis, kidney disease, and lung disease. Finally, people with pSS are at a greater risk of developing B-cell lymphomas. Although there are treatments to alleviate some symptoms of pSS, there is no cure. The aim of NECESSITY is to identify sensitive clinical endpoints that could be used in clinical trials to determine whether a new pSS medicine works or not. In addition, the project aims to identify biological markers that could be used to identify specific subgroups of patients with different types of pSS. Finally, the project plans to run an innovative clinical trial (a multi-arm, multi-stage platform trial) to validate both the newly-defined pSS endpoints and the subgroups identified. Ultimately, the project results will contribute to the development of much-needed new treatments for pSS. In addition, many of the tools and methodologies developed by the project will also be useful for other autoimmune diseases.


Partner del progetto:

EFPIA companies

  • Bristol-Myers Squibb Company Corp, Princeton, NJ, United States
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Institut De Recherches Internationales Servier Iris, Suresnes, France
  • Novartis Pharma AG, Basel, Switzerland

Universities, research organisations, public bodies, non-profit groups

  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Ecrin European Clinical Research Infrastructure Network, Paris, France
  • Ethniko Kai Kapodistriako Panepistimio Athinon, Athens, Greece
  • Fundacio Clinic Per A La Recerca Biomedica, Barcelona, Spain
  • Fundacion Publica Andaluza Progreso Y Salud, Seville , Spain
  • Helse Stavanger Hf, Stavanger, Norway
  • Hopitaux Universitaires De Strasbourg, Strasbourg, France
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • Institut Pasteur, Paris, France
  • Karolinska Institutet, Stockholm, Sweden
  • Queen Mary University Of London, London, United Kingdom
  • The University Of Birmingham, Birmingham, United Kingdom
  • Universita Degli Studi Di Udine, Udine, Italy
  • Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  • Universite De Bretagne Occidentale, Brest, France
  • Universite De Paris, Paris, France
  • Universite Paris Descartes, Paris , France
  • University Of Newcastle Upon Tyne, Newcastle Upon Tyne, United Kingdom
  • Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Innovation Acta S.R.L., Roma, Italy

Patient organisations

  • Association Francaise Gougerot-Sjogren, Courbevoie, France


Date inizio e fine progetto: 01.01.2019 – 31.12.2024

Budget totale del progetto: 15.425.020,00€

Sito web: