Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106574
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2005-03-25
Brief Title:
A Study to Assess the Effect of Tocilizumab DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD 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 2 arm study will compare the safety and efficacy with regard to reduction of signs and symptoms of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug DMARD therapy in patients with moderate to severe active rheumatoid arthritis RA who have had an inadequate response to current DMARD therapy Patients will be randomized to receive tocilizumab 8mgkg iv or placebo iv every 4 weeks in conjunction with stable DMARD therapy 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