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

FACTS & FIGURES
Start Date |
|
End Date |
|
Call |
IMI2 - Call 12
|
Grant agreement number |
806975
|
Type of Action:
RIA (Research and Innovation Action)
Contributions | € |
---|---|
IMI Funding |
8 200 000
|
EFPIA in kind |
7 225 020
|
Total Cost |
15 425 020
|
Summary
Participants Show participants on map
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
Participants | |
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Name | IMI funding in € |
Academisch Ziekenhuis Groningen | 100 768 |
Assistance Publique Hopitaux De Paris | 2 096 640 |
Association Francaise Gougerot-Sjogren | 50 000 |
Ecrin European Clinical Research Infrastructure Network | 621 696 |
Ethniko Kai Kapodistriako Panepistimio Athinon | 100 000 |
Fundacio Clinic Per A La Recerca Biomedica | 207 619 |
Fundacion Publica Andaluza Progreso Y Salud | 50 000 |
Helse Stavanger Hf | 87 500 |
Hopitaux Universitaires De Strasbourg | 300 000 |
Innovation Acta S.R.L. | 300 000 |
Institut National De La Sante Et De La Recherche Medicale | 877 016 |
Institut Pasteur | 118 733 |
Karolinska Institutet | 220 000 |
Queen Mary University Of London | 250 974 |
The University Of Birmingham | 643 394 |
Universita Degli Studi Di Udine | 100 000 |
Universitair Medisch Centrum Utrecht | 140 225 |
Universite De Bretagne Occidentale | 371 311 |
Universite Paris Cite | 596 849 |
Universitetet I Bergen (left the project) | 19 772 |
University Of Newcastle Upon Tyne | 380 573 |
Third parties | |
Name | IMI funding in € |
Centre Hospitalier Regional Et Universitaire De Brest | 18 675 |
Universite Paris-Saclay | 356 819 |
University College Cork - National University Of Ireland, Cork | 191 438 |
Total Cost | 8 200 002 |
Project coordinator
Xavier Mariette
Institut National De La Sante Et De La Recherche Medicale
Xavier Mariette
Institut National De La Sante Et De La Recherche Medicale
LINKS AND DOCUMENTS
Project website
www.necessity-h2020.eu