Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).
Phase 3
Completed
- Conditions
- Crohn's Disease
- Registration Number
- NCT00152425
- Lead Sponsor
- UCB Pharma
- Brief Summary
A 26 week maintenance study of CDP870 in Crohn's disease
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
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.
- Patients aged 18 years or above at screening.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
- Secondary Outcome Measures
Name Time Method In population with CRP ≥ 10 mg/L at baseline; Time to disease progression up to and including Week 26; Proportion of patients with clinical remission at Week 26; Proportion of patients with IBDQ response at Week 26; F-36 sub-scores and change from basel