Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106535
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2005-03-25
Brief Title:
A Study to Assess the Effect of Tocilizumab Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis RA
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo in Combination With Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2013-12
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 respect to a reduction in signs and symptoms and prevention of joint damage of tocilizumab versus placebo both in combination with methotrexate MTX in patients with moderate to severe active rheumatoid arthritis Patients will be randomized to receive tocilizumab 4 mgkg IV tocilizumab 8 mgkg IV or placebo IV every 4 weeks All patients will also receive methotrexate 10-25 mgweek The anticipated time on study treatment is 1-2 years and the target sample size is 500 individuals After completion of the 2 year study participants could participate in the optional 3 year open label extension phase year 3 to 5
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