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NECESSITY SIGNED

NEw Clinical Endpoints in primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients

Total Cost €

EC-Contrib. €

Partnership

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NECESSITY project word cloud

Explore the words cloud of the NECESSITY project. It provides you a very rough idea of what is the project "NECESSITY" about.

spectrum interstitial systemic ouml conferring lymphomas disease limb trials erythematous composite drug 1000 kidney lifetime marketed hamper vasculitis mouth difficulty aid lupus manifestations original accurate biological whereas exocrine arm immunomodulatory heterogeneous inclusion eyes glandular autoimmune organ discriminative risk disturbances arthritis difference shorter drugs extra syndrome expectancy involvement burden licensed points newly pss primary individuals dryness cell 50 glands predictive sj aids synovitis period treatments considerably gren trial successful stratification perform consequence clinical lung stage chance maximizing patients fold broad progression rheumatoid sensitive endpoints persons validate fatigue biomarkers peripheral pain neuropathy placebo 30 usable

Project "NECESSITY" data sheet

The following table provides information about the project.

Coordinator	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	France [FR]
Total cost	15˙425˙020 €
EC max contribution	8˙200˙000 € (53%)
Programme	1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
Code Call	H2020-JTI-IMI2-2017-12-two-stage
Funding Scheme	IMI2-RIA
Starting year	2019
Duration (year-month-day)	from 2019-01-01 to 2024-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	coordinator	1˙233˙834.00
2	ASSISTANCE PUBLIQUE HOPITAUX DE PARIS ASSISTANCE PUBLIQUE HOPITAUX DE PARIS Organization address address: 3 AVENUE VICTORIA city: PARIS postcode: 75000 website: http://www.aphp.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	2˙109˙640.00
3	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	800˙134.00
4	UNIVERSITE DE PARIS UNIVERSITE DE PARIS Organization address address: 85 BD SAINT GERMAIN city: PARIS postcode: 75006 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	596˙848.00
5	UNIVERSITE DE BRETAGNE OCCIDENTALE UNIVERSITE DE BRETAGNE OCCIDENTALE Organization address address: RUE DES ARCHIVES 3 city: BREST postcode: 29238 website: http://www.univ-brest.fr/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (BREST)	participant	389˙986.00
6	UNIVERSITY OF NEWCASTLE UPON TYNE UNIVERSITY OF NEWCASTLE UPON TYNE Organization address address: KINGS GATE city: NEWCASTLE UPON TYNE postcode: NE1 7RU website: http://www.ncl.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWCASTLE UPON TYNE)	participant	380˙572.00
7	THE UNIVERSITY OF BIRMINGHAM THE UNIVERSITY OF BIRMINGHAM Organization address address: Edgbaston city: BIRMINGHAM postcode: B15 2TT website: www.bham.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BIRMINGHAM)	participant	349˙416.00
8	UNIVERSITETET I BERGEN UNIVERSITETET I BERGEN Organization address address: MUSEPLASSEN 1 city: BERGEN postcode: 5020 website: www.uib.no contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (BERGEN)	participant	313˙750.00
9	HOPITAUX UNIVERSITAIRES DE STRASBOURG HOPITAUX UNIVERSITAIRES DE STRASBOURG Organization address address: PLACE DE L HOPITAL 1 city: STRASBOURG CEDEX postcode: 67091 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (STRASBOURG CEDEX)	participant	300˙000.00
10	INNOVATION ACTA S.R.L. INNOVATION ACTA S.R.L. Organization address address: VIA D.A. AZUNI, 9 city: ROMA postcode: 196 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	300˙000.00
11	QUEEN MARY UNIVERSITY OF LONDON QUEEN MARY UNIVERSITY OF LONDON Organization address address: 327 MILE END ROAD city: LONDON postcode: E1 4NS website: http://www.qmul.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	250˙973.00
12	KAROLINSKA INSTITUTET KAROLINSKA INSTITUTET Organization address address: Nobels Vag 5 city: STOCKHOLM postcode: 17177 website: www.ki.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (STOCKHOLM)	participant	220˙000.00
13	FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA Organization address address: CARRER ROSSELLO 149 city: BARCELONA postcode: 8036 website: www.fundacioclinic.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARCELONA)	participant	207˙618.00
14	UNIVERSITAIR MEDISCH CENTRUM UTRECHT UNIVERSITAIR MEDISCH CENTRUM UTRECHT Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX website: www.umcutrecht.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	participant	140˙225.00
15	INSTITUT PASTEUR INSTITUT PASTEUR Organization address address: RUE DU DOCTEUR ROUX 25-28 city: PARIS CEDEX 15 postcode: 75724 website: http://www.pasteur.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS CEDEX 15)	participant	118˙732.00
16	ACADEMISCH ZIEKENHUIS GRONINGEN ACADEMISCH ZIEKENHUIS GRONINGEN Organization address address: HANZEPLEIN 1 city: GRONINGEN postcode: 9713 GZ website: www.umcg.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (GRONINGEN)	participant	100˙767.00
17	ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON Organization address address: 6 CHRISTOU LADA STR city: ATHINA postcode: 10561 website: www.elke.uoa.gr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EL (ATHINA)	participant	100˙000.00
18	UNIVERSITA DEGLI STUDI DI UDINE UNIVERSITA DEGLI STUDI DI UDINE Organization address address: VIA PALLADIO 8 city: UDINE postcode: 33100 website: www.uniud.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (UDINE)	participant	100˙000.00
19	HELSE STAVANGER HF HELSE STAVANGER HF Organization address address: GERD RAGNA BLOCH THORSENS GATE 8 city: STAVANGER postcode: 4011 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (STAVANGER)	participant	87˙500.00
20	ASSOCIATION FRANCAISE GOUGEROT-SJOGREN ASSOCIATION FRANCAISE GOUGEROT-SJOGREN Organization address address: 11 RUE DE L'EVANGILE city: PARIS postcode: 75018 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	50˙000.00
21	FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD Organization address address: AVENIDA AMERICO VESPUCIO 15 EDIF S2 city: SEVILLA postcode: 41092 website: www.juntadeandalucia.es/fundacionprogresoysalud contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (SEVILLA)	participant	50˙000.00
22	BRISTOL-MYERS SQUIBB COMPANY CORP BRISTOL-MYERS SQUIBB COMPANY CORP Organization address address: PARK AVENUE 345 city: NEW YORK postcode: 10154 website: http://www.bms.com/landing/data/index.html contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (NEW YORK)	participant	0.00
23	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. Organization address address: Great West Road 980 city: BRENTFORD postcode: TW89GS website: www.gsk.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BRENTFORD)	participant	0.00
24	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER INSTITUT DE RECHERCHES INTERNATIONALES SERVIER Organization address address: RUE CARNOT 50 city: SURESNES postcode: 92284 website: www.servier.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (SURESNES)	participant	0.00
25	NOVARTIS PHARMA AG NOVARTIS PHARMA AG Organization address address: LICHTSTRASSE 35 city: BASEL postcode: 4056 website: www.novartis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BASEL)	participant	0.00
26	UNIVERSITE PARIS DESCARTES UNIVERSITE PARIS DESCARTES Organization address address: RUE DE L ECOLE DE MEDECINE 12 city: PARIS CEDEX 06 postcode: 75270 website: www.univ-paris5.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS CEDEX 06)	participant	0.00

Map

Project 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.

Deliverables

List of deliverables.
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.

Publications

List of publications.
year	authors and title	journal	last update
2019	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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