Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 3:37 PM
Study NCT ID:
NCT01214733
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2010-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2015-12
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 open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: