CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.
Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .
Livrables
An Ethical Advisory board (EAB) will be defined and formalized in a EAB collaboration report. It will include the list of members, their role and frequency of the meetings.
A shortlist of candidate blood biomarkers for stratifying pSS patients to be further evaluated in Task 4.6.Using the pSS subsets identified in D4.2 to identify blood-based biomarkers characterising these subsets. Blood-based biomarkers may be derived from, but not limited to serum/plasma, whole blood or peripheral mononuclear cells, and the biomarkers may be proteins, metabolities and/or RNA. Priority will be given to biomarkers that are relatively easy to measure accurately and reproducibly using widely available molecular technology.
Initial Exploitation planA preliminary exploitation plan will be createdwhen the project begins and updated yearly. The plan will summarize the strategy and the concrete actions put in place by the NECESSITY Consortium for the optimal protection and exploitation of the results generated by the project
A comprehensive dataset on a tranSMART platform with clinical and biological data from well-characterised pSS cohorts and clinical trials.We will integrate the available datasets from the pSS cohorts and clinical trials available for the NECESSITY project onto a tranSMART platform. It will involve creation and harmonization all the descriptive terms for the clinical and biological data of these datasets
Set of inclusion criteria for the WP6 clinical trial by identifying patients' subsets being the most responsive to treatment based on ESSDAI, ESSPRI and other major outcomes.Identification of patients’ subsets being the most responsive to treatment based on major clinical outcomes, by analysis of data form all previous clinical trial data available at the time of analysis
Communication PolicyA communication Policy will be put in place to ensure that: i) all innovation related activities are captured, assessed, and the IP protected and ii) all NECESSITY Partners will comply with the rules of IMI2 JU Grant Agreement and the IMI2 JU Communication Guide regarding the dissemination activities and the protection of foreground generated within the project
EAB second report on ethical issuesThe EAB will be held at month 26 of the project and minutes prepared.
A list of clinical phenotypic subsets of pSS with differential clinical and/or biological responses to therapies.We will identify clinically and biological meaningful subsets of pSS patients through interrogating the combined dataset of D4.1 using mathematical and statistical modelling
A Shortlist of blood-based biomarkers derived from novel technologies.Similar to D4.3, but this deliverable focus on biomarkers identified using novel technologies which are more exploratory in nature but may enable deeper understandings of the pathobiology of the pSS subsets.
A shortlist of histological parameters to monitor inflammatory and athropic changes in the salivary glandsWe will provide a list of validated parameters, such as percentage of infiltrated area, average infiltrating size. Those will be tested across independent laboratories and used on available samples to generate correlations with measured areas of atrophy.
Final version of the protocol of the NECESSITY trialThe summary of the definitive protocol will be available on nih.gov.
EAB first report on ethical issuesThe EAB will be held at month 12 of the project and minutes prepared.
EAB third report on ethical issuesThe EAB will be held at month 48 of the project and minutes prepared
Initial Dissemination and Communication plan.A preliminary dissemination and communication plan will be createdwhen the project begins and updated yearly. The plan will summarize the strategy and the concrete actions put inplace by the NECESSITY Consortium for the optimal dissemination and communication of the resultsgenerated by the project
A shortlist of candidate blood biomarkers identified within PRECISESADS to be further evaluated in Task 4.6. and 4.7.Similar to D4.3 but data will be based on dataset from the PRECISESADS cohort.
Mid-term Exploitation planA mid-term exploitation plan will be created at M36. The plan will revise and improve the strategy and the concrete actions put in place by the NECESSITY Consortium for the optimal protection and exploitation of the results generated by the project.
Mid-term Communication and Dissemination planA mid-term dissemination and communication plan will be createdat M36. The plan will revise and improve the strategy and the concrete actions put inplace by the NECESSITY Consortium for the optimal dissemination and communication of the results generated by the project.
First version of the protocol of the NECESSITY trial finalizedA first version of the complete NECESSITY trial protocol meeting requirements for submission to health authorities
A shortlist of histological parameters to monitor disease progression and lymphoma development in the salivary glandsWe will validate a series of parameters, able to predict in repeated longitudinal biopsies from the same patients the development of lymphoma. Items considered will include morphometric measurements of lymphoepithelial areas and histological features of the germinal centres.
Identification of a consensual salivary gland US scoring system to be used in the WP6 clinical trial.Definition of a consensual Scoring of salivary gland US
Same as above but with updated inputs from WP1-WP7 on the clinical development plan. Finalize study protocol based on HA, patient group & payer feedback.
First workshop on clinical protocol development sharing opinions of patients, experts and health authoritiesAdvance identification of and signed contracts for external participants; Admin logistics (location, contracts, timing). Creation of materials from draft clinical outputs (from WP1-WP7). Plan information to be included in briefing package to be shared with HAs, patient groups & payers. Plan timing for HA/payer/patient group consultation and feedback.
The NECESSITY website will be accessible on the internet at month 6 and it will be revised and improvedduring the whole course of the action. Part of the website will be password-protected and dedicated to internal communication.
Publications
Auteurs:
Raphaele Seror, Gabriel Baron, Marine Camus, Divi Cornec, Elodie Perrodeau, Simon J Bowman, Michele Bombardieri, Hendrika Bootsma, Jacques-Eric Gottenberg, Benjamin Fisher, Wolfgang Hueber, Joel A van Roon, Valérie Devauchelle-Pensec, Peter Gergely, Xavier Mariette, Raphael Porcher, NECESSITY WP5 - STAR development working group;
Publié dans:
Ann Rheum Dis ., 2022, Page(s) ahead of print, ISSN 0003-4967
Éditeur:
BMJ Publishing Group
Auteurs:
Diana Trutschel, Pierre Bost, Xavier Mariette, Vincent Bondet, Alba Llibre, et al, Milieu Interieur, ASSESS investigators, and NECESSITY consortium
Publié dans:
Arthritis Rheumatol., 2022, ISSN 2326-5205
Éditeur:
American College of Rheumatology
DOI:
10.1002/art.42265
Auteurs:
Pierre-Marie Duret, Cedric Schleiss,Lou Kawka,Nicolas Meyer, Tao YeAlain Saraux,
Valérie Devauchelle-Pensec, Raphaele Seror,Claire Larroche, Aleth Perdriger,Jean Sibilia,
Laurent Vallat, Luc-Matthieu Fornecker, Gaetane Nocturne,Xavier Mariette,
and Jacques-Eric Gottenberg
Publié dans:
Arthritis & Rheumatology, 2023, ISSN 2326-5205
Éditeur:
Wiley Periodicals LLC
DOI:
10.1002/art.42550
Auteurs:
Brahim, I, Lamard, M, Benyoussef, A-A, Quellec, G.
Publié dans:
Clin Experiment Ophthalmol., 2022, ISSN 1442-9071
Éditeur:
Wiley Press
DOI:
10.1111/ceo.14119
Auteurs:
Elodie Rivière, Juliette Pascaud, Nicolas Tchitchek, Saida Boudaoud, Audrey Paoletti, Bineta Ly, Anastasia Dupré, Hua Chen, Alice Thai, Norm Allaire, Bernd Jagla, Michael Mingueneau, Gaetane Nocturne, Xavier Mariette
Publié dans:
Annals of the Rheumatic Diseases, Numéro 79/11, 2020, Page(s) 1468-1477, ISSN 0003-4967
Éditeur:
BMJ Publishing Group
DOI:
10.1136/annrheumdis-2019-216588
Auteurs:
Jessica Tarn, Dennis Lendrem, Michael Barnes, John Casement1 and Wan-Fai Ng
Publié dans:
Front Immunol, Numéro 16643224, 2022, ISSN 1664-3224
Éditeur:
Frontiers Media S.A.
DOI:
10.3389/fimmu.2022.864448
Auteurs:
Elena Pontarini,Elisabetta Sciacca,Farzana Chowdhury,Sofia Grigoriadou,Felice Rivellese,
William J. Murray-Brown, Davide Lucchesi,Liliante Fossati-Jimack,Alessandra Nerviani,
Edyta Jaworska,Giulia Maria Ghirardi,Chiara Giacomassi,Paul Emery,Wan Fai Ng Nurhan Sutcliffe,Colin Everett, Catherine Fernandez, Anwar Tappuni,Raphael Seror,Xavier Mariette,Raphael Porcher,Giulia Cavallaro,Alfredo Pulvirenti
Publié dans:
Arthritis & Rheumatology, 2023, ISSN 2326-5205
Éditeur:
Wiley Periodicals LLC
DOI:
10.1002/art.42772
Auteurs:
Alexis Collins, Dennis Lendrem, James Wason, Jessica Tarn, Nadia Howard‑Tripp, Iris Bodewes, Marjan A. Versnel, Jacques‑Eric Gottenberg, Raphaele Seror, Xavier Mariette, Wan‑Fai.
Publié dans:
Rheumatology International, 2021, ISSN 1559-0836
Éditeur:
John Wiley and Sons Ltd
DOI:
10.1007/s00296-021-04927-y
Auteurs:
Suzanne Arends, Liseth de Wolff, Liselotte Deroo, Gwenny M Verstappen, Arjan Vissink, Frans G M Kroese, Dirk Elewaut, Isabelle Peene, Hendrika Bootsma
Publié dans:
Clinical and Experimental Rheumatology, 2022, ISSN 0392-856X
Éditeur:
Pacini Editore SpA
DOI:
10.55563/clinexprheumatol/yagocb
Auteurs:
Seror R, Nocturne G, Mariette X.
Publié dans:
Nat. Rev Rheumatol., 2021, ISSN 1759-4804
Éditeur:
Springer Nature
DOI:
10.1038/s41584-021-00634-x
Auteurs:
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
Publié dans:
Arthritis Care & Research, Numéro 72/1, 2019, Page(s) 78-87, ISSN 2151-464X
Éditeur:
John Wiley & Sons Inc.
DOI:
10.1002/acr.23839
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