Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202852
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2005-09-13
Brief Title:
A Placebo-Controlled Double-Blinded Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate Study P04280COMPLETED
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
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:
Prior to the first infusion patients will be randomized into one of two groups placebo or infliximab All patients will continue to receive the same does of methotrexate MTX during the study as received prior to the study The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis RA at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial
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