CORDIS
EU research results

CORDIS

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

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

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.

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

Address

Rue De Tolbiac 101
75654 Paris

France

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 233 834,75

Participants (24)

Sort alphabetically

Sort by EU Contribution

Expand all

THE UNIVERSITY OF BIRMINGHAM

United Kingdom

EU Contribution

€ 349 416,25

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 220 000

UNIVERSITY OF NEWCASTLE UPON TYNE

United Kingdom

EU Contribution

€ 380 572,50

HOPITAUX UNIVERSITAIRES DE STRASBOURG

France

EU Contribution

€ 300 000

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands

EU Contribution

€ 140 225

UNIVERSITE DE BRETAGNE OCCIDENTALE

France

EU Contribution

€ 389 986,25

FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD

Spain

EU Contribution

€ 50 000

ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

Greece

EU Contribution

€ 100 000

UNIVERSITE PARIS DESCARTES

France

EU Contribution

€ 596 848,75

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 2 109 640

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 800 134

UNIVERSITETET I BERGEN

Norway

EU Contribution

€ 313 750

INNOVATION ACTA S.R.L.

Italy

EU Contribution

€ 300 000

ASSOCIATION FRANCAISE GOUGEROT-SJOGREN

France

EU Contribution

€ 50 000

QUEEN MARY UNIVERSITY OF LONDON

United Kingdom

EU Contribution

€ 250 973,75

UNIVERSITA DEGLI STUDI DI UDINE

Italy

EU Contribution

€ 100 000

INSTITUT PASTEUR

France

EU Contribution

€ 118 732,50

HELSE STAVANGER HF

Norway

EU Contribution

€ 87 500

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 100 767,50

FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA

Spain

EU Contribution

€ 207 618,75

NOVARTIS PHARMA AG

Switzerland

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.

United Kingdom

BRISTOL-MYERS SQUIBB COMPANY CORP

United States

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

France

Project information

Grant agreement ID: 806975

Status

Ongoing project

  • Start date

    1 January 2019

  • End date

    31 December 2024

Funded under:

H2020-EU.3.1.7.

  • Overall budget:

    € 15 485 964,84

  • EU contribution

    € 8 200 000

Coordinated by:

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France