News from BIOCYCLE

Edouard Louis

Edouard Louis © ECCO

The BIOCYCLE project has now been ongoing for almost 2.5 years. This project, funded by the European Commission under the Horizon 2020 programme, aims at exploring different aspects of the question of treatment de-escalation in moderate-severe Crohn’s Disease, first requiring a combination therapy with anti-TNF and antimetabolites to control the disease. Once the disease has been stabilised, an unsolved question is to whether it is possible to de-escalate therapy. This question is important for several reasons including safety, tolerance, quality of life or costs to name the most prominent. 

BIOCYCLE includes a randomised three arms, controlled clinical trial on 300 patients in five European countries, several patients and health care providers’ surveys in Europe and the USA, a biomarker research programme and pharmaco-economic analysis. ECCO is mainly involved in the monitoring of the project (through the SciCom and the ClinCom) and is the work package leader for dissemination of the results. BIOCYCLE is a 6-year-long project and was launched two years ago in April 2015.

The global aim of BIOCYCLE is to try and bring an integrated multidimensional and tailored response to this difficult question of treatment de-escalation in Crohn’s Disease, also taking into account patients’ preferences and perspectives.

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BIOCYCLE Consortuim © ECCO

What has been achieved so far?

According to the Grant Agreement, two work packages have mainly progressed over the first 2.5 years of the project: the SPARE clinical trial and the patients and health care providers’ surveys.

The clinical trial is progressing well with over 150 patients screened in France, Belgium, United Kingdom, Germany, Sweden, and most recently Australia. Indeed, an Australian consortium coordinated by the St-Vincent Centre in Melbourne has joined the adventure and a first patient was screened in Australia in November 2017. The recruitment has been extended till end of 2018. According to current recruitment rate, we should be able to reach our 300 expected patients by that date.

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The health care providers’ and patients’ surveys are coordinated by the Crohn's and Colitis Foundation in the USA and by the patients’ association AFA in France, with the help of ECCO for the recruitment of doctors in Europe. The health care providers’ survey has been completed and results were recently presented at ECCO 2017 and DDW 2017. The patients’ survey was launched in France and the USA in February 2017. It has closed in France before the summer, with over 300 patients included and has recently closed in the USA (over 100 patients responded). The analysis of this survey has been performed and first results will be presented at ECCO 2018.

The pharmaco-economic work package led by Gothenburg University has also recently started and will first try to develop a theoretical pharmaco-economic model for drug withdrawal in this situation. First results should be available by the spring 2018.

The next scientific and financial report in the setting of Horizon 2020 is due by the end of March 2017. The project will then reach half of its life

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For more information visit biocycle-project.eu;
EU reference: grant agreement No 633168 – BIOCYCLE (PHC-13-2014)

Posted in ECCO News, Volume 12, Issue 4