Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419809
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2007-01-05
Brief Title:
SB-681323-Methotrexate Interaction Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2012-01
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:
SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions such as RA Previous p38 MAP-kinase inhibitors have been hindered in development by liver toxicity Methotrexate common treatment for RA patients also has potential liver toxicity This study was an enabling study to determine the safety of co-administration of the two compounds with respect to liver function
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