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BIOlogical therapy CYCLEs towards tailored, needs-driven, safer and cost-effective management of Crohn’s disease

Deliverables

"BIOCYCLE Scientific and financial progress report #2"

Scientific progress reports in compliance with the EC-Grant agreement at M36: -CHU and sCINNAMIC will put in place a management platform to: - maintain and monitor the work plan, the timely production of Deliverables, the Milestones including making alerts if deviation appears compared to tables 3.1.c (deliverables) and 3.2.a (Milestones); - To ensure that there is adequate collaboration between the clinical [SPARE] and non-clinical teams working on different work packages within the project; -Coordinate internal and contractual periodic reporting; -Coordinate financial and administrative issues: establish and maintain financial records, coordinate cost statements submission, follow-up of EC payments, distribute partner shares according to the Consortium Agreement. To administer project resources (human and financial); -Maintain contractual documents (EG-CA, Consortium Agreement) Special attention will be brought to consistency of management procedures across the SPARE study and the global BIOCYCLE Project including in terms of financial reporting. Clear information and assistance will be provided to the SPARE Study team including the Project Assistants of the Co-sponsors on the rules and expectations of the Commission for financial reporting especially e.g., for helping to gather the needed information among the clinical sites [third parties of the Co-sponsors]. CHU and sCINNAMIC (nested at CHU) will hold weekly short Project Management Meetings for enabling seamless day-to-day monitoring of the Project Progress and discuss possible managerial and financial issues encountered as well as how to solve specific problems. An extranet platform will be set up (member restricted access with individual login and password) to manage confidential information to be shared by all partners, such as: (i) Grant Agreement related documents (grant agreement and annexes including technical annex, consortium agreement), reports, charts, updated financial plans, etc., (ii) contact information (address book), (iii) information about activities conducted by each group (iv) access to scientific data bases, protocols, SOPs and internet‐based data management tools developed in BIOCYCLE, (v) communication rules and guidelines (vi) ethical and regulatory documents, and (vii) knowledge management‐related documents A web‐based reporting tool accessible from the extranet will be set up for the collection reports elements (scientific and financial reports). Harmonization and final edition of the periodic reports will be performed by CHU in collaboration with sCINNAMIC for the management‐related sections, based on the information compiled by the tool. -Monitor project progress, identification and trouble shooting of technical and organisational problems, strategic/technical co-ordination meetings; -Supervise achievements and propose evolution of the project according to those achievements; -Organise the yearly Steering Committee meeting in parallel to the ECCO congress (February 2016-2021) Attendees: CHU, sCINNAMIC, GETAID&Co-Sponsors, and WP-Leaders Typical agenda: - Evaluation of the level of achievements compared to the objectives, main problems/solutions and next steps; - Decisions for improving the efficiency of the consortium, re-orientation of parts of the work, if necessary, and means to implement them; - Approval of the propositions of the WP-Leaders, the Knowledge-Management Platform and the Data Management Platform; - Decision on the general structure for preparing the Scientific and financial reports (at M36)

Submission package

Final version of study protocol as submitted to regulators ethics committeesno need to change deliverable if later amendmentsRegistration number of clinical study in a WHO or ICMJE approved registryPlease note Result posting for the study must be possibleApprovals ethics committees and national competent authority if applicable required for invitation enrolment of first subject in at least one clinical centre

Final SPARE Clinical Study report

Idem delivrable D358 Final study report Dec 2022 M93Delivrable D35Description of workThe study conduct is fully and extensively described in the document entitled Essential information regarding the SPARE clinical study Briefly the trial is a multicenter randomized three arms openlabeled trial in Crohns disease in stable remission under infliximabantimetabolites Combo therapy comparing infliximabantimetabolites continuation vs infliximab discontinuation vs antimetabolites discontinuationThe study will be performed in 7 countries France UK Belgium Sweden Germany The Netherlands and Australia according to a cosponsorship organisation the GETAID in France being the main sponsor and CHU UEDIN RSSUH Charit AMC and MELBOURNE being the cosponsors 200220 patients will be recruited in 6080 centresAll the data of the clinical trial will be collected through a unique centralized eCRF which will be developed in collaboration with INSERM who will be responsible of the data management WP7 and statistical analysis WP8The preparatory phase prior to the first investigators meeting will be ready by the start of the BIOCYCLE Project 042015 All authorizations for performing the study in the 7 countries will be obtained on the latest in Q42014 already obtained in BE and FR CRF will be approved The clinical study team will also be completed as well as the clinical sites identification and contracts Thus between April 2015 Study Start and March 2021 Study End the main steps and milestones are1 Investigator meeting April 2015 M12First patient screened April 2015 M13Last patient screened March 2019 M484 Last patient complete March 2021 M725 Database lock Oct 2021 M796 Statistical analysis WP7 and WP8 Nov 2021 M807 Draft report available Mar 2022 M84Each clinical site will also perform biological samples collection and local storage by following the protocols summarized in EXHIBIT 8 of the Essential information regarding the SPARE clinical study The samples will be ready to be transferred to the central Biobank for biomarkers analyses according to WP4 tasks description

BIOCYCLE Website

The BIOCYCLE website will be the firstlevel information center on the general progress of the project sCINNAMIC will be in charge of designing and updating the website which will give separate access to patients associations the medical community and other stakeholders eg policymakers needing information to better understand the objectives of the Project and how their achievement may have an impact on their own activities decisions and orientation The BIOCYCLE website will act as the firstlevel interface between the BIOCYCLE consortium and the outside world for collecting and sorting questions redirecting specific queries to the right members of the consortium and as such to measure the interest of the public and stakeholders for this projectThe website will also regularly post eg short newsletters on major advances of the BIOCYCLE Project publications prepared during the Project and short tutorialsA secured access to the Participants will include templates monitoring and reporting procedures for scientific and financial reporting summaries on crossdisciplinary discussions used definitions meeting notes access to general documentation

Publications

Withdrawal of infliximab or anti-metabolite therapy in Crohn’s Disease patients in sustained remission on combination therapy: A randomized unblinded controlled trial (SPARE)

Author(s): E Louis J, M Resche-Rigon, D Laharie, J Satsangi, N Ding, J Preiss, G D’Haens, L Picon, P Bossuyt, L Vuitton, P Irving, Y Bouhnik, S Viennot, C Lamb, R Pollock, F Baert, M Nachury, F Mathurin, C Gilletta, J F Colombel, E Hertervig
Published in: Journal of Crohn's and Colitis, Issue 16(1), 2022, Page(s) Page i001, ISSN 1873-9946
Publisher: Elsevier Science
DOI: 10.1093/ecco-jcc/jjab232.000

ECCO Topical Review on Biological Treatment Cycles in Crohn’s Disease

Author(s): Nurulamin M Noor, Paula Sousa, Dominik Bettenworth, Fernando Gomollón, Triana Lobaton, Peter Bossuyt, Maria Jose Casanova, Nik S Ding, Gabriele Dragoni, Federica Furfaro, Patrick F van Rheenen, Maria Chaparro, Javier P Gisbert, Edouard Louis, Konstantinos Papamichail
Published in: Journal of Crohn's and Colitis, Issue 17(7), 2023, Page(s) Pages 1031–1045, ISSN 1873-9946
Publisher: Elsevier Science
DOI: 10.1093/ecco-jcc/jjad001

Withdrawal of infliximab or concomitant immunosuppressant therapy in patients with Crohn's disease on combination therapy (SPARE): a multicentre, open-label, randomised controlled trial

Author(s): Prof Edouard Louis, MD Prof Matthieu Resche-Rigon, MD * Prof David Laharie, MD * Prof Jack Satsangi, DPhil * Nik Ding, MBBS PhD Prof Britta Siegmund, MD Prof Geert D'Haens, MD Laurence Picon, MD Peter Bossuyt, MD Prof Lucine Vuitton, MD Peter Irving, MD Stephanie Viennot, MD Christopher A Lamb, MBBS PhD Richard Pollok, MD Filip Baert, MD Maria Nachury, MD Prof Mathurin Fumery, MD Cyrielle Gillett
Published in: Lancet Gastroenterology & Hepatology, Issue 8(3), 2023, Page(s) 215-227, ISSN 0140-6736
Publisher: The Lancet Publishing Group
DOI: 10.1016/s2468-1253(22)00385-5

De-escalation of immunomodulator and biological therapy in inflammatory bowel disease

Author(s): Thomas P Chapman, Catarina Frias Gomes, Edouard Louis, Jean-Frédéric Colombel, Jack Satsangi
Published in: The Lancet Gastroenterology & Hepatology, Issue 5/1, 2020, Page(s) 63-79, ISSN 2468-1253
Publisher: The Lancet
DOI: 10.1016/s2468-1253(19)30186-4

Systematic Review of Effects of Withdrawal of Immunomodulators or Biologic Agents From Patients With Inflammatory Bowel Disease

Author(s): Joana Torres, Ray K. Boyapati, Nicholas A. Kennedy, Edouard Louis, Jean-Frédéric Colombel, Jack Satsangi
Published in: Gastroenterology, Issue 149/7, 2015, Page(s) 1716-1730, ISSN 0016-5085
Publisher: W. B. Saunders Co., Ltd.
DOI: 10.1053/j.gastro.2015.08.055

How to Apply for and Secure EU Funding for Collaborative IBD Research Projects

Author(s): Jack Satsangi, Olivier Kitten, Marcela Chavez, Rahul Kalla, Nadege Prel, Marie-Alice Meuwis, Stephanie Scott, Illaria Bonetti, Nicholas T. Ventham, Edouard Louis
Published in: Journal of Crohn's and Colitis, Issue 10/3, 2016, Page(s) 363-370, ISSN 1873-9946
Publisher: Elsevier Science
DOI: 10.1093/ecco-jcc/jjv237

European Crohn’s and Colitis Organisation Topical Review on Treatment Withdrawal [‘Exit Strategies’] in Inflammatory Bowel Disease

Author(s): Glen Doherty, Konstantinos H Katsanos, Johan Burisch, Matthieu Allez, Konstantinos Papamichael, Andreas Stallmach, Ren Mao, Ingrid Prytz Berset, Javier P Gisbert, Shaji Sebastian, Jarosław Kierkuś, Loris Lopetuso, Edyta Szymanska, Edouard Louis
Published in: Journal of Crohn's and Colitis, Issue 12/1, 2017, Page(s) 17-31, ISSN 1873-9946
Publisher: Elsevier Science
DOI: 10.1093/ecco-jcc/jjx101

Stopping Biologics in IBD—What Is the Evidence?

Author(s): Edouard Louis
Published in: Inflammatory Bowel Diseases, 2018, ISSN 1078-0998
Publisher: Lippincott Williams & Wilkins Ltd.
DOI: 10.1093/ibd/izx098

Integrated Care for Crohn’s Disease: A Plea for the Development of Clinical Decision Support Systems

Author(s): Nathalie Y Pauwen, Edouard Louis, Corey Siegel, Jean-Frederic Colombel, Jean Macq
Published in: Journal of Crohn's and Colitis, Issue 12/12, 2018, Page(s) 1499-1504, ISSN 1873-9946
Publisher: Elsevier Science
DOI: 10.1093/ecco-jcc/jjy128

Tailoring Biologic or Immunomodulator Treatment Withdrawal in Inflammatory Bowel Disease

Author(s): Edouard Louis
Published in: Frontiers in Medicine, Issue 6, 2020, ISSN 2296-858X
Publisher: Frontiers in Medicine
DOI: 10.3389/fmed.2019.00302

Crohn’s disease patients’ and gastroenterologists’ perspectives towards de-escalating inflammatory bowel disease therapy

Author(s): Corey A. Siegel, Kimberly D. Thompson, Danielle Walls, Jan Gollins, Anne Buisson, Alain Olympie, Laurent Beaugerie, Jean-Frederic Colombel, Edouard Louis
Published in: Clinical Gastroenterology and Hepatology, 2019, ISSN 1542-3565
Publisher: W. B. Saunders Co., Ltd.
DOI: 10.1016/j.cgh.2019.11.062

The Cost-effectiveness of Biological Therapy Cycles in the Management of Crohn’s Disease

Author(s): Kristian Bolin, Erik Hertervig, Edouard Louis
Published in: Journal of Crohn's and Colitis, Issue 13/10, 2019, Page(s) 1323-1333, ISSN 1873-9946
Publisher: Elsevier Science
DOI: 10.1093/ecco-jcc/jjz063

A serum metabolite panel predicts Crohn’s disease relapse in patients discontinuing infliximab and continuing antimetabolite therapy: sub-analysis of the SPARE Trial

Author(s): D Radford-Smith, J Satsangi, E Louis, D Laharie, N Ding, B Siegmund, G D’Haens, H Erik, A Yates, D Anthony, J F Colombel, F Probert GETAID and the SPARE-Biocycle research group
Published in: Journal of Crohn's and Colitis, Issue 16(1), 2022, Page(s) i458-i460
Publisher: Oxford Academic
DOI: 10.1093/ecco-jcc/jjab232.621

Distinct biological profiles associated with the risk of short-term relapse and mid/long-term relapse in Crohn’s disease patients stopping infliximab

Author(s): N Pierre, V A Huynh-Thu, D Baiwir, G Mazzucchelli, M Fléron, L Trzpiot, G Eppe, D Laharie, J Satsangi, J F Colombel, E Hertervig, M A Meuwis, E Louis, GETAID and the SPARE-Biocycle research group
Published in: Journal of Crohn's and Colitis, Issue 17(1), 2023, Page(s) i3-i6
Publisher: Oxoford Academic
DOI: 10.1093/ecco-jcc/jjac190.0002

Report from IIS Award Winner 2021: Nicolas Pierre

Author(s): NICOLAS PIERRE, ECCO MEMBER
Published in: ECCO News 2021, Issue 16(3), 2021
Publisher: ECCO

Stopping Anti-TNF in Crohn’s Disease Remitters: Pros and Cons: The Pros

Author(s): Edouard Louis
Published in: Inflamm Intest Dis, Issue 7 (1), 2022, Page(s) 64–68, ISSN 2296-9365
Publisher: Karger
DOI: 10.1159/000520942

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