Study design
Crohn's disease
REMISSION, CROHN'S DISEASE
SPARE was a multicentre, international, open-label, randomised controlled trial involving 64 hospitals in seven countries (Australia, Belgium, France, Germany, Netherlands, UK, Sweden). The aim of the trial was to compare three treatment strategies in patients with Crohn's disease who had achieved steroid-free clinical remission on combination therapy with infliximab and immunosuppressant therapy (thiopurine or methotrexate): continuing combination therapy; stopping infliximab and continuing immunosuppressant therapy as monotherapy; or stopping immunosuppressant therapy and continuing infliximab monotherapy. The study protocol was approved by the relevant ethics committees or institutional review boards of each country and was executed in compliance with the Declaration of Helsinki, Good Clinical Practice guidelines, and applicable local regulations. Protocol deviations (eg, violations of inclusion or exclusion criteria or incorrect treatment or dose) were monitored at study entry and throughout the study. All protocol deviations were assessed in real time for their effect on data integrity and patient safety to determine whether the patient should continue in the study. The study duration was 104 weeks. Major changes in the protocol are explained in the 