Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454584
Status:
COMPLETED
Last Update Posted:
2012-11-21
First Post:
2007-03-28
Brief Title:
An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2012-10
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:
The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis
Detailed Description:
This is a multicenter randomized study medication assigned by chance active-controlled parallel 3-arm study Patients will be randomly allocation to treatments available by chance assigned in 355 ratio to receive one of three treatments groups The three treatment groups are Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4 Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4 Group 3 - Etanercept 50 mg two times per week through week 12 The total duration for each participant will be up to 64 weeks approximately 16 months The active-controlled portion of the study is from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2 dose levels of CNTO 1275 will be evaluated Treatment after Week 12 is dependent on Physicians Global Assessment PGA response at Week 12 and initial treatment assignment Patients will receive 2 subcutaneous injections of CNTO 1275 either 45 or 90 mg doses or twice weekly injections of etanercept during the first twelve weeks of the study Patients may receive two additional doses of CNTO 1275 either 45 or 90 mg doses up to week 44
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 |
|---|---|---|---|
| 2006-003444-30 | EUDRACT_NUMBER | Centocor | None |
| C0743T12 | OTHER | None | None |