Titolo 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: https://www.necessity-h2020.eu/

Contatti: salvatore.devita@uniud.it