The core of the project is a randomized controlled trial: SPARE clinical trial. Crohn’s disease patients with sustained remission without steroids for at least 6 months and treated with a combination therapy (infliximab and anti-metabolites) will be randomized into three arms: first arm where both infliximab and anti-metabolites are continued, second arm where infliximab is stopped and third arm where anti-metabolites are stopped. The enrolment of 200-220 patients is planned in France, UK, Sweden, Germany, Belgium, the Netherlands and Australia. The primary objective of the trial is to assess the relapse rate and the time spent in remission in the three arms. Classical biomarkers (CRP, calprotectin) and new ones will also be assessed in their ability to correctly predict the risk of relapse and the disease progression.
Health economics impact of treatment cycles will be evaluated with comparative cost-of-illness and cost-effectiveness calculations between the three arms of the SPARE clinical study. Main factors that drive the direct healthcare costs burden will be identified. Finally, cost models for completing specific recommendations according to patients’ characteristics and risks profiles will be created.
The “acceptance vs. reluctance” will be assessed through surveys carried out among patients, caregivers and healthcare systems. This set of surveys will provide profiles of patients and healthcare providers in terms of their readiness to use treatment cycles during remission, list of main hurdles that may delay the implementation of a new regimen and consolidated networks with stakeholders.
All BIOCYCLE data (effectiveness, clinical benefits, costs and real world data) will be synthesized, analyzed and assessed to measure the relevance and the degree of readiness of the treatment cycle concept to be transferred to the healthcare decision makers prior to its dissemination.
The most appropriate dissemination actions and communication channels to implement the new treatment strategy will be identified. The central part will be the preparation of an innovative decision-making tool and corresponding guidelines including all the considerations to elect the best treatment option based on specific needs.