A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

• Phase: Phase 3

Details

• Lead Sponsor: UCB Pharma
• Treatments: Certolizumab Pegol

Criteria

Inclusion Criteria:

• Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3*. *Vienna Classification (1998)

• Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.

• Male and female aged 18 years or above at screening.

• Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

Exclusion Criteria:

• Crohn's Disease Related

• Fistula abscess present at screening.

• Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.

• Short bowel syndrome.

• Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).

• Positive stool laboratory results for enteric pathogens.