Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329550
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2006-05-22
Brief Title:
Maintenance Study of Certolizumab Pegol CZP in Crohns Disease
Sponsor:
UCB Japan Co Ltd
Organization:
UCB Pharma
Study Overview
Official Title:
A 26-week Multi-center Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohns Disease Patients Who Showed Clinical Efficacy in a Remission Induction Study Study C87037 NCT00291668 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 is a multi-centre open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohns disease in the double-blind main study C87037 NCT00291668
Detailed Description:
In the double-blind main study subjects were dosed at Weeks 0 2 and 4 with the primary outcome clinical response being assessed at Week 6 Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study The first visit in this extension study was 2 weeks after Week 6 ie Week 8 Subjects in this extension study were dosed at Weeks 8 12 16 20 and 24 with the primary outcome clinical response being assessed at Week 26 All week numbers quoted are relative to the start of the double-blind main study
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 |
|---|---|---|---|
| 2014-004354-34 | EUDRACT_NUMBER | None | None |