Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036153
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2002-05-08
Brief Title:
Study to Assess Efficacy of Tacrolimus Methotrexate Versus Placebo Methotrexate in Treatment of Rheumatoid Arthritis
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Randomized Double-Blind Study to Assess the Efficacy of Tacrolimus Prograf Methotrexate Vs Placebo Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of the combination of tacrolimus methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate
Detailed Description:
This is a Phase III 6 month randomized double-blind placebo controlled multi-center study with a 6 month open-label extension Patients will be randomized to the tacrolimus methotrexate arm or the placebo methotrexate arm in a ratio of 21 Patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study
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