Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316771
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-04-20
Brief Title:
A Study of P38 Inhibitor 4 in Patients With Active Rheumatoid Arthritis RA on Stable Methotrexate Therapy
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis RA on Stable Methotrexate MTX Therapy
Status:
COMPLETED
Status Verified Date:
2016-11
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 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor 4 in patients with RA currently having an inadequate clinical response to methotrexate Patients will be randomized to receive P38 Inhibitor 4 50150 or 300 qd poand 25 or 75 bid po or placebo and will remain on the stable dose of methotrexate The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals
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