Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296257
Status:
TERMINATED
Last Update Posted:
2009-03-13
First Post:
2006-02-22
Brief Title:
Assessment of Safety Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
Sponsor:
Dainippon Sumitomo Pharma Europe LTd
Organization:
Dainippon Sumitomo Pharma Europe LTd
Study Overview
Official Title:
A Phase 2 Multi-Centre Randomised Double Blind Placebo Controlled Study Evaluating the Efficacy Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug DMARD SMP-114 120 mg and 240 mg Once Daily Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis
Status:
TERMINATED
Status Verified Date:
2009-03
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:
To compare the efficacy of SMP-114 120 and 240 mgd versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20 improvement in RA ACR20 at week 24 The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone
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