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)

Phase

Condition

Inflammatory Bowel Disease

Colic

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT00152490

C87031

Ages > 18
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to studyentry) either by radiological, endoscopic or histological evidence, affecting theterminal 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 firstdose 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 astable dose throughout the duration of the study, although steroids may be taperedstarting at Weeks 8 to 12.

Exclusion

Exclusion Criteria:

Crohn's Disease Related
Fistula abscess present at screening.
Stricturing type disease with symptoms or signs of non-inflammatory mechanicalobstruction or bowel perforation in last 3 months.
Short bowel syndrome.
Functional colostomy or ileostomy (note: patients who have had a temporary stoma inthe past, which has been reversed, are eligible to enter the study).
Positive stool laboratory results for enteric pathogens.

Study Design

December 01, 2003

May 31, 2005

Study Description

Receiving immunosuppressants (azathioprine/6-MP/methotrexate) at Week 0 or not.

604 patients will be enrolled with 1006 patients screened (to allow for 25% screen failures between screening and Week 0 and expected presentation at Screening of 60% of patients with CRP < 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).