Trial Information

Anti TNF α Improves Endothelial Dysfunction in Crohns' Disease Patients

Crohn's Disease (CD) is a life long disease that mainly affects young adults. There is
evidence That gut tissue injury is the result of an abnormal immune response that involved
multiple non immune cellular systems including the intestinal microvascular endothelial
cell. Moreover, clinical studies have shown that 1-7% of irritable bowel disease (IBD)
patients suffer from arterial and venous thromboembolic complication.

Chronic inflammation has a major role in the development and propagation of endothelial
dysfunction, which can lead to coronary artery disease.

Endothelial dysfunction has been described in patients with various and diverse chronic
inflammatory conditions. Over the last few years, dysfunction of vascular endothelium has
been widely recognized as the first step in the development of atherosclerosis. Several
inflammatory mediators, such as C-reactive protein (CRP), Tumor Necrosis Factor α, (TNF α),
nitric oxide (NO), vascular endothelial growth factor, CD-40, interleukin-6 (IL-6), which
are up-regulated in IBD, also are known to impact vascular impact.

The normal endothelium produces a vasodilatatory response to ischemia referred to us as
reactive hyperemia. Shear stress on the blood vessel wall leads to the production and
release vasodilatation. With endothelial dysfunction there is often either a blunted
vasodilatatory in response to ischemic event, and chronic inflammation.

The hypothesis of this study is that patients with Crohn's disease have an increased
incidence of endothelial dysfunction, which can be corrected or improved by treatment with
anti TNF α.

The purpose of our study was to assess endothelial function in patients with Crohn's
Disease, before and after treatment (steroids, immunomodulators, and anti TNF α). This study
assessed the presence of endothelial dysfunction in patients with Crohn's disease and
evaluated the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this
abnormality.

In this study we will preformed an endothelial function test before and after treatment by
Endopath device from Itamar medical, FDA approved.

Safety- Each subject will be screened by clinical history, physical examination,
electrocardiogram, chest X-ray, Mantoux test (PPD), routine chemical analysis, and
biomarkers.

The study protocol has been approved by the local institutional review board.