Status:
COMPLETED
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)
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT00152490
Start Date
December 1 2003
End Date
May 1 2005
Last Update
September 9 2013
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