Ignite Creation Date:
2024-05-05 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00732875
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2008-08-08
Brief Title:
A Trial of Anti-TNF Chimeric Monoclonal Antibody cA2 in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate Extension PartStudy P05645COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Placebo-controlled Double-blinded Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody cA2 in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment Open-label Extension Part
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This trial is extension part of the P04280 placebo-controlled double-blind randomized study of chronic treatment with infliximab in approximately 140 patients NCT00202852 This study will be conducted at 6 study centers in South Korea After completion of the last follow-up visit at Week 30 and code break in main double-blind trial subjects randomized to the placebo group and those who were treated with an infliximab-containing regimen who maintained clinical response at the time of study completion will be provided with open-label infliximab for treatment of their conditions and additional safety data will be collected
Detailed Description:
None
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