Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267956
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2005-12-20
Brief Title:
An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Trial of CNTO 1275 a Fully Human Anti-IL-12 Monoclonal Antibody Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
Status:
COMPLETED
Status Verified Date:
2013-05
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 effectiveness and safety of CNTO 1275 ustekinumab in patients with psoriatic arthritis
Detailed Description:
This study is a randomized the study drug is assigned by chance double-blind neither physician nor the patient knows the treatment that the patient receives parallel-group each group of patients will be treated at the same time multicenter study to evaluate the effectiveness and safety of CNTO 1275 compared to placebo in the treatment of patients with active psoriatic arthritis Patients will be randomized in 11 ratio to 1 of 2 treatment groups CNTO 1275 63 mg and placebo Patients will be randomly assigned to receive study medication up to Week 12 and will be followed through Week 36 to monitor safety and efficacy Patients randomly assigned to placebo will crossover to receive CNTO 1275 63 mg at Weeks 12 and 16 Patients randomly assigned to CNTO 1275 will receive placebo at Weeks 12 and 16 to maintain the blind The duration of participation for an individual patient in the study will be up to 36 weeks
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 |
|---|---|---|---|
| C0743T10 | OTHER | None | None |
| 2005-003525-92 | EUDRACT_NUMBER | Centocor | None |