Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329420
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2006-05-22
Brief Title:
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 NCT00291668
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multi-center Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohns Disease Patients Who Showed no Clinical Efficacy in a Remission Induction Study Study C87037 But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals
Status:
COMPLETED
Status Verified Date:
2015-02
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:
This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks dosed at Weeks 16 20 24 28 and 32 in subjects with active Crohns disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study C87037 NCT00291668 but subsequently showed clinical response at Week 14 to repeated induction therapy dosed at Weeks 8 10 and 12 in this extension study
Detailed Description:
This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 NCT00291668 All Week numbers quoted are relative to the start of the double-blind main study The first visit in this extension study is at Week 8 and the final efficacy assessment in this extension study 26 weeks later is at Week 34
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 |
|---|---|---|---|
| 2014-004400-30 | EUDRACT_NUMBER | None | None |