Mucosal Healing Study in Crohn's Disease (CD)

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

Inclusion Criteria:

• Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
• Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

Exclusion Criteria:

• Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
• History of tuberculosis or positive tests for tuberculosis at screening
• All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial