Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17
cells and other immune cell types) or biomarkers can be used to predict the response or lack
of response to treatment with Infliximab. If so, characteristics of the immune cells may also
unveil the mechanisms behind lack of response to Infliximab.
Design: a prospective, observational study with three arms. In the treatment group, 35
patients with Crohn's disease about to start Infliximab-treatment are recruited. They have
blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks
of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated
once. All treatment and follow-up are according to national guidelines, and data from this
study is not used by the clinicians.
Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is
investigated using flow cytometry. From plasma and serum samples, various proteins
(biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor
alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical
history) are extracted from various registries.