Skip to main content

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.

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 action

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Address
Rue De Tolbiac 101
75654 Paris
France
Activity type
Research Organisations
EU contribution
€ 1 233 834,75

Participants (24)

THE UNIVERSITY OF BIRMINGHAM
United Kingdom
EU contribution
€ 643 394,25
Address
Edgbaston
B15 2TT Birmingham
Activity type
Higher or Secondary Education Establishments
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 220 000
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
EU contribution
€ 380 572,50
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
Activity type
Higher or Secondary Education Establishments
HOPITAUX UNIVERSITAIRES DE STRASBOURG
France
EU contribution
€ 300 000
Address
Place De L Hopital 1
67091 Strasbourg Cedex
Activity type
Research Organisations
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 140 225
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE BRETAGNE OCCIDENTALE
France
EU contribution
€ 389 986,25
Address
Rue Des Archives 3
29238 Brest
Activity type
Higher or Secondary Education Establishments
FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD
Spain
EU contribution
€ 50 000
Address
Avenida Americo Vespucio 15 Edif S2
41092 Sevilla
Activity type
Research Organisations
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU contribution
€ 100 000
Address
6 Christou Lada Str
10561 Athina
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE PARIS
France
EU contribution
€ 596 848,75
Address
85 Bd Saint Germain
75006 Paris
Activity type
Higher or Secondary Education Establishments
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 2 096 640
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 813 134
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
UNIVERSITETET I BERGEN

Participation ended

Norway
EU contribution
€ 19 772
Address
Museplassen 1
5020 Bergen
Activity type
Higher or Secondary Education Establishments
INNOVATION ACTA S.R.L.
Italy
EU contribution
€ 300 000
Address
Via D.a. Azuni, 9
00196 Roma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASSOCIATION FRANCAISE GOUGEROT-SJOGREN
France
EU contribution
€ 50 000
Address
11 Rue De L'evangile
75018 Paris
Activity type
Other
QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 250 973,75
Address
327 Mile End Road
E1 4NS London
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI UDINE
Italy
EU contribution
€ 100 000
Address
Via Palladio 8
33100 Udine
Activity type
Higher or Secondary Education Establishments
INSTITUT PASTEUR
France
EU contribution
€ 118 732,50
Address
Rue Du Docteur Roux 25-28
75724 Paris Cedex 15
Activity type
Research Organisations
HELSE STAVANGER HF
Norway
EU contribution
€ 87 500
Address
Gerd Ragna Bloch Thorsens Gate 8
4011 Stavanger
Activity type
Other
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 100 767,50
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
Spain
EU contribution
€ 207 618,75
Address
Carrer Rossello 149
08036 Barcelona
Activity type
Research Organisations
NOVARTIS PHARMA AG
Switzerland
EU contribution
€ 0
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
EU contribution
€ 0
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BRISTOL-MYERS SQUIBB COMPANY CORP
United States
EU contribution
€ 0
Address
Park Avenue 345
10154 New York
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT DE RECHERCHES INTERNATIONALES SERVIER IRIS
France
EU contribution
€ 0
Address
Rue Carnot 50
92284 Courbevoie
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)