Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207714
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2005-09-13
Brief Title:
An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Randomized Double-blind Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicenter randomized double-blind placebo-controlled 5-arm dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab CNTO 148 50 or 100 mg at either 2- or 4- week intervals in subjects with active RA despite MTX therapy
Detailed Description:
This is an experimental medical research study The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis
Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20 22 28 36 44 for 48 weeks
Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20 22 28 36 44 for 48 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 |
|---|---|---|---|
| C0524T02 | OTHER | Centocor | None |