Risultati finali
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 D42 to identify bloodbased biomarkers characterising these subsets Bloodbased biomarkers may be derived from but not limited to serumplasma whole blood or peripheral mononuclear cells and the biomarkers may be proteins metabolities andor 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 created when 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 D43 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 nihgov
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 created when 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 dissemination and communication of the results generated 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 D43 but data will be based on dataset from the PRECISESADS cohort
Mid-term Exploitation planA midterm 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 midterm 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 WP1WP7 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 improved during the whole course of the action. Part of the website will be password-protected and dedicated to internal communication.
Pubblicazioni
Autori:
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;
Pubblicato in:
Ann Rheum Dis ., 2022, Pagina/e ahead of print, ISSN 0003-4967
Editore:
BMJ Publishing Group
Autori:
Diana Trutschel, Pierre Bost, Xavier Mariette, Vincent Bondet, Alba Llibre, et al, Milieu Interieur, ASSESS investigators, and NECESSITY consortium
Pubblicato in:
Arthritis Rheumatol., 2022, ISSN 2326-5205
Editore:
American College of Rheumatology
DOI:
10.1002/art.42265
Autori:
Brahim, I, Lamard, M, Benyoussef, A-A, Quellec, G.
Pubblicato in:
Clin Experiment Ophthalmol., 2022, ISSN 1442-9071
Editore:
Wiley Press
DOI:
10.1111/ceo.14119
Autori:
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
Pubblicato in:
Annals of the Rheumatic Diseases, Numero 79/11, 2020, Pagina/e 1468-1477, ISSN 0003-4967
Editore:
BMJ Publishing Group
DOI:
10.1136/annrheumdis-2019-216588
Autori:
Jessica Tarn, Dennis Lendrem, Michael Barnes, John Casement1 and Wan-Fai Ng
Pubblicato in:
Front Immunol, Numero 16643224, 2022, ISSN 1664-3224
Editore:
Frontiers Media S.A.
DOI:
10.3389/fimmu.2022.864448
Autori:
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.
Pubblicato in:
Rheumatology International, 2021, ISSN 1559-0836
Editore:
John Wiley and Sons Ltd
DOI:
10.1007/s00296-021-04927-y
Autori:
Suzanne Arends, Liseth de Wolff, Liselotte Deroo, Gwenny M Verstappen, Arjan Vissink, Frans G M Kroese, Dirk Elewaut, Isabelle Peene, Hendrika Bootsma
Pubblicato in:
Clinical and Experimental Rheumatology, 2022, ISSN 0392-856X
Editore:
Pacini Editore SpA
DOI:
10.55563/clinexprheumatol/yagocb
Autori:
Seror R, Nocturne G, Mariette X.
Pubblicato in:
Nat. Rev Rheumatol., 2021, ISSN 1759-4804
Editore:
Springer Nature
DOI:
10.1038/s41584-021-00634-x
Autori:
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
Pubblicato in:
Arthritis Care & Research, Numero 72/1, 2019, Pagina/e 78-87, ISSN 2151-464X
Editore:
John Wiley & Sons Inc.
DOI:
10.1002/acr.23839
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