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NECESSITY SIGNED

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

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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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.

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

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 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

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

year authors and title journal last update
List of publications.
2019 Daniel S. Hammenfors, Valéria Valim, Blanca E. R. G. Bica, Sandra G. Pasoto, Vibke Lilleby, Juan Carlos Nieto‐González, Clovis A. Silva, Esther Mossel, Rosa M. R. Pereira, Aline Coelho, Hendrika Bootsma, Akaluck Thatayatikom, Johan G. Brun, Malin V. Jonsson
Juvenile Sjögren\'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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