New clinical endpoints in primary Sjögren’s syndrome: an interventional trial based on stratifying patients


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.

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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 Paris Cite, 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
Third parties
  • Centre Hospitalier Regional Et Universitaire De Brest, Brest, France
  • Hospital Clinic De Barcelona, Barcelona, Spain
  • Universite Paris-Saclay, Saint Aubin, France
  • University College Cork - National University Of Ireland, Cork, Cork, Ireland

NameIHI funding in €
Academisch Ziekenhuis Groningen100 768
Assistance Publique Hopitaux De Paris2 096 640
Association Francaise Gougerot-Sjogren50 000
Ecrin European Clinical Research Infrastructure Network621 696
Ethniko Kai Kapodistriako Panepistimio Athinon100 000
Fundacio Clinic Per A La Recerca Biomedica207 619
Fundacion Publica Andaluza Progreso Y Salud50 000
Helse Stavanger Hf87 500
Hopitaux Universitaires De Strasbourg300 000
Innovation Acta S.R.L.300 000
Institut National De La Sante Et De La Recherche Medicale877 016
Institut Pasteur118 733
Karolinska Institutet220 000
Queen Mary University Of London250 974
The University Of Birmingham643 394
Universita Degli Studi Di Udine100 000
Universitair Medisch Centrum Utrecht140 225
Universite De Bretagne Occidentale371 311
Universite Paris Cite596 849
Universitetet I Bergen (left the project)19 772
University Of Newcastle Upon Tyne380 573
Third parties
NameFunding in €
Centre Hospitalier Regional Et Universitaire De Brest18 675
Universite Paris-Saclay356 819
University College Cork - National University Of Ireland, Cork191 438
Total Cost8 200 002