Discontinuation of infliximab therapy in patients with Crohn's disease during sustained complete remission

Crohn's disease is a chronic inflammatory bowel disease. The biological drug Remicade is used in patients with Crohn's disease when normal treatment is inadequate. About one in three of the patients starting treatment with Remicade have sustained good effect over several years. However, serious side effects such as; infections, allergic reactions and concerns about long-term safety, with suspected increased risk of developing cancer, necessitate exploring strategies for when and in which patients to stop (discontinue) treatment again.

Currently there are no evidence-based set guidelines for how long Remicade treatment should be continued in patients in whom it is working well. Today the decision is typically based on an individual assessment of the pros and cons of continuing treatment. There is no solid evidence that discontinuation is the best approach, however, a recent study showed that many patients with very few risk factors (i.e. in complete remission), could stop Remicade treatment with low risk of the disease to flare. The intention of this study is to examine whether Remicade can be discontinued safely in the complete-remission patient group.

We will achieve this by performing a Nordic clinical trial that examines whether Remicade treatment can be stopped beneficially in patients in whom the disease is completely inactive, as determined by both a physicians' assessment, examination of the intestines and blood tests. Patients will be randomized to continue Remicade treatment or receive an inactive substance (placebo). Patients are monitored continuously (every 8 weeks) throughout a year. Furthermore, we will examine the concentration of Remicade and antibodies against Remicade in the blood (at different time-points) can be used to determine how long to treat with the biological drug.