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