Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349752
Status:
TERMINATED
Last Update Posted:
2018-08-09
First Post:
2006-06-30
Brief Title:
Corticosteroid Sparing Effect of Certolizumab in Crohns Disease
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Phase IIIb Multicenter Double-blind Placebo-controlledRandomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohns Disease
Status:
TERMINATED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was stopped early due to slow enrolment of this population With no safety concerns the study continued normally for subjects already recruited
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03559660
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
COSPAR1
Brief Summary:
The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohns disease Subjects had to be in remission CDAI150 and receiving corticosteroids at a dose no higher than 30 mgday prednisone or equivalent during the week prior to randomization
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-003870-88 | EUDRACT_NUMBER | None | None |