Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361335
Status:
COMPLETED
Last Update Posted:
2014-07-29
First Post:
2006-08-04
Brief Title:
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Trial of Golimumab a Fully Human Anti-TNFa Monoclonal Antibody Administered Intravenously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Status:
COMPLETED
Status Verified Date:
2014-07
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 assess the clinical effectiveness and safety of golimumab intravenous IV infusions every 12 weeks with or without Methotrexate MTX compared with MTX alone in patients with active rheumatoid arthritis RA despite concurrent MTX treatment In addition the safety of subcutaneous SC golimumab injections following transition from IV golimumab infusions will also be evaluated
Detailed Description:
This is a Phase III double blind neither investigator nor participant knows the treatment received placebo-controlled an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study multicenter 5-arm treatment groups study of golimumab at 2 doses given with or without MTX over a period of 30 minutes for at least 48 weeks in patients with active RA despite concurrent MTX therapy The study consists of a treatment period of golimumab IV infusions IV Period which ranges from 48 weeks to approximately 140 weeks assuming an enrollment period of approximately 92 weeks and a long-term optional extension period Extension Study in which golimumab SC injections will be given for 24 weeks The end of study will be the time the last participant completes the Week E-40 visit Extension Study for safety follow-up assessments For the IV Period participants will be randomly assigned to 1 of the 5 treatment groups in a 11111 ratio approximately 125 patients per group At Week 16 and Week 24 joint assessment results will be used to allow participants to enter early escape and dose regimen adjustment respectively in a blinded fashion Treatment will be unblinded after the 48-week database lock and participants will be given the option to participate in the Extension Study and receive SC injections of 50mg golimumab with or without MTX every 4 weeks for an additional 24 weeks Safety will be monitored throughout the study The entire study duration IV Period plus Extension Study for each participant will range from 88 weeks up to 192 weeks assuming an enrollment period of approximately 92 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 |
|---|---|---|---|
| 2005-003232-21 | EUDRACT_NUMBER | Centocor Inc | None |
| C0524T12 | OTHER | None | None |