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 3
Completed
- Conditions
- Crohn's Disease
- Registration Number
- NCT00152490
- Lead Sponsor
- UCB Pharma
- 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 0 and expected presentation at Screening of 60% of patients with CRP \< 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 604
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In the population with CRP ≥ 10 mg/L at baseline Clinical response at week 6 Clinical response at week 6 and week 26
- Secondary Outcome Measures
Name Time Method In the population with CRP ≥ 10 mg/L at baseline - % patients in clinical remission at Week 6; % patients in clinical remission at both Week 6 and Week 26; % patients with IBDQ response at Week 6; % patients with IBDQ response at both Week 6 and Week 2