Explore the words cloud of the NECESSITY project. It provides you a very rough idea of what is the project "NECESSITY" about.
The following table provides information about the project.
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
|Coordinator Country||France [FR]|
|Total cost||15˙425˙020 €|
|EC max contribution||8˙200˙000 € (53%)|
1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
|Duration (year-month-day)||from 2019-01-01 to 2024-12-31|
Take a look of project's partnership.
|1||INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE||FR (PARIS)||coordinator||1˙233˙834.00|
|2||ASSISTANCE PUBLIQUE HOPITAUX DE PARIS||FR (PARIS)||participant||2˙109˙640.00|
|3||ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK||FR (PARIS)||participant||800˙134.00|
|4||UNIVERSITE DE PARIS||FR (PARIS)||participant||596˙848.00|
|5||UNIVERSITE DE BRETAGNE OCCIDENTALE||FR (BREST)||participant||389˙986.00|
|6||UNIVERSITY OF NEWCASTLE UPON TYNE||UK (NEWCASTLE UPON TYNE)||participant||380˙572.00|
|7||THE UNIVERSITY OF BIRMINGHAM||UK (BIRMINGHAM)||participant||349˙416.00|
|8||UNIVERSITETET I BERGEN||NO (BERGEN)||participant||313˙750.00|
|9||HOPITAUX UNIVERSITAIRES DE STRASBOURG||FR (STRASBOURG CEDEX)||participant||300˙000.00|
|10||INNOVATION ACTA S.R.L.||IT (ROMA)||participant||300˙000.00|
|11||QUEEN MARY UNIVERSITY OF LONDON||UK (LONDON)||participant||250˙973.00|
|12||KAROLINSKA INSTITUTET||SE (STOCKHOLM)||participant||220˙000.00|
|13||FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA||ES (BARCELONA)||participant||207˙618.00|
|14||UNIVERSITAIR MEDISCH CENTRUM UTRECHT||NL (UTRECHT)||participant||140˙225.00|
|15||INSTITUT PASTEUR||FR (PARIS CEDEX 15)||participant||118˙732.00|
|16||ACADEMISCH ZIEKENHUIS GRONINGEN||NL (GRONINGEN)||participant||100˙767.00|
|17||ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON||EL (ATHINA)||participant||100˙000.00|
|18||UNIVERSITA DEGLI STUDI DI UDINE||IT (UDINE)||participant||100˙000.00|
|19||HELSE STAVANGER HF||NO (STAVANGER)||participant||87˙500.00|
|20||ASSOCIATION FRANCAISE GOUGEROT-SJOGREN||FR (PARIS)||participant||50˙000.00|
|21||FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD||ES (SEVILLA)||participant||50˙000.00|
|22||BRISTOL-MYERS SQUIBB COMPANY CORP||US (NEW YORK)||participant||0.00|
|23||GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.||UK (BRENTFORD)||participant||0.00|
|24||INSTITUT DE RECHERCHES INTERNATIONALES SERVIER||FR (SURESNES)||participant||0.00|
|25||NOVARTIS PHARMA AG||CH (BASEL)||participant||0.00|
|26||UNIVERSITE PARIS DESCARTES||FR (PARIS CEDEX 06)||participant||0.00|
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.
|First workshop on clinical protocol development sharing opinions of patients, experts and health authorities||Websites, patent fillings, videos etc.||2020-03-24 11:33:48|
|EAB first report on ethical issues||Documents, reports||2020-03-24 11:32:59|
|Initial Exploitation plan||Documents, reports||2020-03-11 16:23:54|
|Initial Dissemination and Communication plan.||Documents, reports||2020-03-11 16:23:54|
|Communication Policy||Documents, reports||2020-03-11 16:23:54|
|First version of the protocol of the NECESSITY trial finalized||Documents, reports||2020-03-11 16:23:54|
|EAB cooperation report that will summarize the Experts profiles and their roles.||Documents, reports||2020-03-11 16:23:54|
|NECESSITY website||Demonstrators, pilots, prototypes||2020-03-11 16:23:54|
Take a look to the deliverables list in detail: detailed list of NECESSITY deliverables.
|year||authors and title||journal||last update|
Daniel S. Hammenfors, ValÃ©ria Valim, Blanca E. R. G. Bica, Sandra G. Pasoto, Vibke Lilleby, Juan Carlos Nietoâ€GonzÃ¡lez, Clovis A. Silva, Esther Mossel, Rosa M. R. Pereira, Aline Coelho, Hendrika Bootsma, Akaluck Thatayatikom, Johan G. Brun, Malin V. Jonsson
Juvenile SjÃ¶gren\'s Syndrome: Clinical Characteristics With Focus on Salivary Gland Ultrasonography
published pages: 78-87, ISSN: 2151-464X, DOI: 10.1002/acr.23839
|Arthritis Care & Research 72/1||2020-03-11|
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The information about "NECESSITY" are provided by the European Opendata Portal: CORDIS opendata.
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