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Leistungen
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 serum/saliva based biomarkers to monitor disease progression and damage in the salivary glands (öffnet in neuem Fenster)We will generate a list of biomarkers in the serum and blood that better reflect in the extent of histological damage in the samples analysed. and the diverse morphometric items identified.
A shortlist of candidate blood biomarkers for stratifying pSS patients to be further evaluated in Task 4.6. (öffnet in neuem Fenster)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 plan (öffnet in neuem Fenster)A 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. (öffnet in neuem Fenster)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. (öffnet in neuem Fenster)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 Policy (öffnet in neuem Fenster)A 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 issues (öffnet in neuem Fenster)The 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. (öffnet in neuem Fenster)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. (öffnet in neuem Fenster)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 glands (öffnet in neuem Fenster)We 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 trial (öffnet in neuem Fenster)The summary of the definitive protocol will be available on nih.gov.
EAB first report on ethical issues (öffnet in neuem Fenster)The EAB will be held at month 12 of the project and minutes prepared.
EAB third report on ethical issues (öffnet in neuem Fenster)The EAB will be held at month 48 of the project and minutes prepared
Initial Dissemination and Communication plan. (öffnet in neuem Fenster)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. (öffnet in neuem Fenster)Similar to D4.3 but data will be based on dataset from the PRECISESADS cohort.
Mid-term Exploitation plan (öffnet in neuem Fenster)A 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 plan (öffnet in neuem Fenster)A 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 finalized (öffnet in neuem Fenster)A 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 glands (öffnet in neuem Fenster)We 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. (öffnet in neuem Fenster)Definition of a consensual Scoring of salivary gland US
Analytics on data; identify specific data needs & statistically assess to incorporate into workshop.Same as above but with updated inputs from WP1-WP7. Provide data readout and results to HA, patient groups & payers for feedback on acceptance of endpoints, clinically meaningful change measurements, PROs, etc. in Sjogren’s.
Second workshop sharing opinions of patients, experts and health authorities (öffnet in neuem Fenster)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 authorities (öffnet in neuem Fenster)Advance 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.
Veröffentlichungen
Autoren:
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;
Veröffentlicht in:
Ann Rheum Dis ., 2022, Seite(n) ahead of print, ISSN 0003-4967
Herausgeber:
BMJ Publishing Group
Autoren:
Laurie Georgel, Anas-Alexis Benyoussef, Sofian Berrouiguet, Dewi Guellec, Guillermo Carvajal Alegria, Thierry Marhadour, Sandrine Jousse-Joulin, Béatrice Cochener-Lamard, Marc Labetoulle, Jacques-Eric Gottenberg, Tristan Bourcier, Gaétane Nocturne, Alain Saraux, Xavier Mariette, Maëlys Consigny, Michel Gravey, Valérie Devauchelle-Pensec, Raphaele Seror, Divi Cornec
Veröffentlicht in:
RMD Open, Ausgabe 10, 2024, Seite(n) e004526, ISSN 2056-5933
Herausgeber:
BMJ Publishing Group Ltd
DOI:
10.1136/rmdopen-2024-004526
Autoren:
Diana Trutschel, Pierre Bost, Xavier Mariette, Vincent Bondet, Alba Llibre, et al, Milieu Interieur, ASSESS investigators, and NECESSITY consortium
Veröffentlicht in:
Arthritis Rheumatol., 2022, ISSN 2326-5205
Herausgeber:
American College of Rheumatology
DOI:
10.1002/art.42265
Autoren:
Safae Hamkour, Eefje HM van der Heijden, Ana P Lopes, Sofie L M Blokland, Cornelis P J Bekker, Cornelia G Van Helden-Meeuwsen, Marjan A Versnel, Aike A Kruize, Timothy RDJ Radstake, Helen L Leavis, Maarten R Hillen, Joel AG van Roon
Veröffentlicht in:
RMD Open, Ausgabe 9, 2023, Seite(n) e002979, ISSN 2056-5933
Herausgeber:
BMJ Publishing Group
DOI:
10.1136/rmdopen-2023-002979
Autoren:
Renaud Felten, Anne-Perrine Foray, Pascal Schneider, Cindy Marquet, Coralie Pecquet, Fanny Monneaux, Hélène Dumortier, Jean Sibilia, Fabrice Valette, Lucienne Chatenoud, Jacques-Eric Gottenberg
Veröffentlicht in:
RMD Open, Ausgabe 10, 2024, Seite(n) e004112, ISSN 2056-5933
Herausgeber:
BMJ Publishing Group Ltd.
DOI:
10.1136/rmdopen-2024-004112
Autoren:
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
Veröffentlicht in:
Arthritis & Rheumatology, 2023, ISSN 2326-5205
Herausgeber:
Wiley Periodicals LLC
DOI:
10.1002/art.42550
Autoren:
Brahim, I, Lamard, M, Benyoussef, A-A, Quellec, G.
Veröffentlicht in:
Clin Experiment Ophthalmol., 2022, ISSN 1442-9071
Herausgeber:
Wiley Press
DOI:
10.1111/ceo.14119
Autoren:
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
Veröffentlicht in:
Annals of the Rheumatic Diseases, Ausgabe 79/11, 2020, Seite(n) 1468-1477, ISSN 0003-4967
Herausgeber:
BMJ Publishing Group
DOI:
10.1136/annrheumdis-2019-216588
Autoren:
Yann Nguyen, Gaëtane Nocturne, Julien Henry, Wan-Fai Ng, Rakiba Belkhir, Frédéric Desmoulins, Elisabeth Bergé, Jacques Morel, Aleth Perdriger, Emmanuelle Dernis, Valérie Devauchelle-Pensec, Damien Sène, Philippe Dieudé, Marion Couderc, Anne-Laure Fauchais, Claire Larroche, Olivier Vittecoq, Carine Salliot, Eric Hachulla, Véronique Le Guern, Jacques-Eric Gottenberg, Xavier Mariette, Raphaè
Veröffentlicht in:
The Lancet Rheumatology, Ausgabe 6, 2024, Seite(n) e216-e225, ISSN 2665-9913
Herausgeber:
Elsevier
DOI:
10.1016/s2665-9913(23)00340-5
Autoren:
Lou Kawka, Renaud Felten, Cédric Schleiss, Jean-Daniel Fauny, Pauline Le Van Quyen, Hélène Dumortier, Fanny Monneaux, Jacques-Eric Gottenberg
Veröffentlicht in:
RMD Open, Ausgabe 9, 2023, Seite(n) e003051, ISSN 2056-5933
Herausgeber:
RMD open
DOI:
10.1136/rmdopen-2023-003051
Autoren:
Yann Nguyen, Maxime Beydon, Jacques‐Eric Gottenberg, Jacques Morel, Aleth Perdriger, Emmanuelle Dernis, Divi Cornec, Valérie Devauchelle‐Pensec, Damien Sène, Philippe Dieudé, Marion Couderc, Anne‐Laure Fauchais, Claire Larroche, Olivier Vittecoq, Carine Salliot, Eric Hachulla, Véronique Le Guern, Xavier Mariette, Raphaèle Seror, Gaëtane Nocturne
Veröffentlicht in:
Arthritis & Rheumatology, 2025, ISSN 2326-5191
Herausgeber:
Hoboken
DOI:
10.1002/art.43096
Autoren:
Elodie Rivière, Juliette Pascaud, Alexandre Virone, Anastasia Dupré, Bineta Ly, Audrey Paoletti, Raphaèle Seror, Nicolas Tchitchek, Michael Mingueneau, Nikaïa Smith, Darragh Duffy, Lydie Cassard, Nathalie Chaput, Sabrina Pengam, Vanessa Gauttier, Nicolas Poirier, Xavier Mariette, Gaetane Nocturne
Veröffentlicht in:
Arthritis & Rheumatology, Ausgabe 73, 2023, Seite(n) 631-640, ISSN 2326-5191
Herausgeber:
Arthritis and Rheumatology
DOI:
10.1002/art.41558
Autoren:
Jessica Tarn, Dennis Lendrem, Michael Barnes, John Casement1 and Wan-Fai Ng
Veröffentlicht in:
Front Immunol, Ausgabe 16643224, 2022, ISSN 1664-3224
Herausgeber:
Frontiers Media S.A.
DOI:
10.3389/fimmu.2022.864448
Autoren:
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
Veröffentlicht in:
Arthritis & Rheumatology, 2023, ISSN 2326-5205
Herausgeber:
Wiley Periodicals LLC
DOI:
10.1002/art.42772
Autoren:
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.
Veröffentlicht in:
Rheumatology International, 2021, ISSN 1559-0836
Herausgeber:
John Wiley and Sons Ltd
DOI:
10.1007/s00296-021-04927-y
Autoren:
Cheïma Boudjeniba, Perrine Soret, Diana Trutschel, Antoine Hamon, Valentin Baloche, Bastien Chassagnol, Emiko Desvaux, Antoine Bichat, Audrey Aussy, Philippe Moingeon, Céline Lefebvre, Sandra Hubert, Marta Alarcon-Riquelmé, Wan-Fai Ng, Jacques-Eric Gottenberg, Benno Schwikowski, Michele Bombardieri, Joel A.G. van Roon, Xavier Mariette, Mickaël Guedj, Etienne Birmele, Laurence Laigle, Etienne B
Veröffentlicht in:
Clinical Immunology, Ausgabe 264, 2025, Seite(n) 110241, ISSN 1521-6616
Herausgeber:
Academic Press
DOI:
10.1016/j.clim.2024.110241
Autoren:
Joe Scott Berry, Jessica Tarn, John Casement, Pierre-Marie Duret, Lauren Scott, Karl Wood, Svein-Joar Johnsen, Gunnel Nordmark, Valérie Devauchelle-Pensec, Raphaele Seror, Benjamin Fisher, Fransesca Barone, Simon J Bowman, Michele Bombardieri, Dennis Lendrem, Renaud Felten, Jacques-Eric Gottenberg, Wan-Fai Ng
Veröffentlicht in:
Annals of the Rheumatic Diseases, Ausgabe 83, 2025, Seite(n) 88-95, ISSN 0003-4967
Herausgeber:
BMJ Publishing Group
DOI:
10.1136/ard-2023-224503
Autoren:
Suzanne Arends, Liseth de Wolff, Liselotte Deroo, Gwenny M Verstappen, Arjan Vissink, Frans G M Kroese, Dirk Elewaut, Isabelle Peene, Hendrika Bootsma
Veröffentlicht in:
Clinical and Experimental Rheumatology, 2022, ISSN 0392-856X
Herausgeber:
Pacini Editore SpA
DOI:
10.55563/clinexprheumatol/yagocb
Autoren:
Seror R, Nocturne G, Mariette X.
Veröffentlicht in:
Nat. Rev Rheumatol., 2021, ISSN 1759-4804
Herausgeber:
Springer Nature
DOI:
10.1038/s41584-021-00634-x
Autoren:
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
Veröffentlicht in:
Arthritis Care & Research, Ausgabe 72/1, 2019, Seite(n) 78-87, ISSN 2151-464X
Herausgeber:
John Wiley & Sons Inc.
DOI:
10.1002/acr.23839
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