Objective
Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disease (AID) involving 0.5 to 3/1000 persons. The disease affects exocrine glands leading to dryness of the eyes and the mouth and is associated with fatigue and limb pain. In 30% to 50% of the patients, systemic and extra-glandular manifestations may develop. The spectrum of extra-glandular manifestations in pSS is broad and includes vasculitis, peripheral neuropathy, synovitis, kidney involvement and interstitial lung disease. Moreover, pSS patients have a 10 to 20-fold higher risk of developing B cell lymphomas, conferring shorter lifetime expectancy to these patients.
Whereas 10 new targeted-immunomodulatory treatments have been marketed for rheumatoid arthritis in the past 20 years, only one drug has been licensed for other systemic AIDs, such as pSS and systemic erythematous lupus in the same period. There are several factors that may hamper the development of successful drugs for AID. Being multi-organ, these AIDs are considerably heterogeneous among individuals both in terms of clinical manifestations and biological disturbances, with, as a consequence, a great difficulty to set-up accurate composite clinical end-points sensitive to change and usable in clinical trials. In this project, our objectives are:
• To develop and assess sensitive clinical endpoints, for use in future clinical trials, able to evaluate response to drug treatments in patients with pSS with high disease burden and/or systemic involvement,
• To identify and evaluate discriminative biomarkers for stratification of pSS patients predictive of organ involvement and disease progression and thus available for inclusion in clinical trials,
• To set-up and perform an original multi-arm multi-stage clinical trial to validate the newly defined pSS endpoints and the identified biomarkers, by maximizing the chance of finding a difference between the placebo arm and the treated arm.
Field of science
- /medical and health sciences/basic medicine/immunology/autoimmune diseases
- /medical and health sciences/health sciences/infectious disease/RNA virus/hiv
Call for proposal
H2020-JTI-IMI2-2017-12-two-stage
See other projects for this call
Funding Scheme
IMI2-RIA - Research and Innovation actionCoordinator
75654 Paris
France
Participants (24)
B15 2TT Birmingham
17177 Stockholm
NE1 7RU Newcastle Upon Tyne
67091 Strasbourg Cedex
3584 CX Utrecht
29238 Brest
41092 Sevilla
10561 Athina
75006 Paris
75000 Paris
75013 Paris
Participation ended
5020 Bergen
00196 Roma
75018 Paris
E1 4NS London
33100 Udine
75724 Paris Cedex 15
4011 Stavanger
9713 GZ Groningen
08036 Barcelona
4056 Basel
TW89GS Brentford
10154 New York
92284 Courbevoie