Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152490
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2005-09-08
Brief Title:
A Study to Test the Effect of CDP870 in the Treatment of Crohns Disease Over 26 Weeks Comparing CDP870 to a Dummy Drug Placebo
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Phase III Multi-national Multi-centre Double-blind Placebo-controlled Parallel Group 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc Dosed at Weeks 0 2 4 Then 4-weekly to Week 24 in the Treatment of Patients With Active Crohns Disease
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 26 week study to examine the efficacy safety and pharmacokinetics of CDP870 in Crohns disease
Detailed Description:
Receiving immunosuppressants azathioprine6-MPmethotrexate 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 mgL and 40 of patients with CRP 10 mgL
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 mgL and 40 of patients with CRP 10 mgL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None