Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160706
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2005-09-08
Brief Title:
A follow-on Safety Study in Subjects With Crohns Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 NCT00152490 or CDP870-032 NCT00152425 Due to an Exacerbation of Crohns Disease
Sponsor:
UCB Pharma SA
Organization:
UCB Pharma
Study Overview
Official Title:
A Phase III Multi-national Multi-centre Open Label Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc Dosed at Weeks 0 2 and 4 Then Every 4 Weeks in the Treatment of Patients With Active Crohns Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohns Disease
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03559660
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
PRECiSE 4
Brief Summary:
A follow-on safety study in subjects with Crohns Disease who have previously been withdrawn from the double-blind study CDP870-031 NCT00152490 or CDP870-032 NCT00152425 due to an exacerbation of Crohns Disease
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 |
|---|---|---|---|
| 2005-002623-13 | EUDRACT_NUMBER | None | None |