This was a global Phase IIb study of a novel biological agent to treat Crohn’s disease for a big Chinese pharmaceutical company. By the moment the Sponsor contacted us their trial had been in active enrollment phase for almost a year in 12 sites in the USA. The company was under an extreme pressure to enroll 50 subjects in six months. In this study OCT provided the following clinical research services to the client:
Average enrollment per site per month
Crohn’s disease is a chronic inflammatory bowel disease (IBD) which may affect any part of the gastrointestinal tract. All layers of the intestine may be inflamed and with ulcers in Crohn's disease, while ulcerative colitis only involves the innermost lining of the colon.
The causes of Crohn’s Disease are not well understood - most experts agree that the immune system of people with Crohn's disease reacts abnormally. The disease is considered hereditary. In most cases it affects the lower part of the small intestine, ileum. Crohn's is more prevalent among adults between the ages of 15 and 35. The disease is most common among people of eastern European backgrounds. The incidence of Crohn's disease in Russia is 1.5 per 100000.