Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320216
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2006-04-28
Brief Title:
A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase II Randomized Double-blind Placebo-controlled Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 Human Monoclonal Antibody to IL-12 in Subjects With Moderate to Severe Psoriasis
Status:
COMPLETED
Status Verified Date:
2015-03
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 evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis
Detailed Description:
This is a randomized the study medication is assigned by chance double blind neither physician nor patient knows the treatment that the patient receives parallel-group multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis the most common type of psoriasis The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses Patients who inadequately respond to their treatment may receive one additional dose Patients will be monitored for the safety throughout the 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 |
|---|---|---|---|
| C0379T04 | OTHER | Centocor | None |