Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106522
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2005-03-25
Brief Title:
A Study to Assess the Effect of Tocilizumab Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF 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 3 arm study will compare the safety and efficacy with regard to reduction of signs and symptoms of tocilizumab versus placebo in combination with methotrexate MTX in patients with moderate to severe active rheumatoid arthritis RA currently on MTX therapy and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor anti-TNF agent Patients will be randomized to receive tocilizumab 4mgkg iv tocilizumab 8mgkg or placebo iv every 4 weeks All patients will also receive methotrexate 10-25mgweek The anticipated time on study treatment is 3-12 months and the target sample size is 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