Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-31 @ 4:20 AM
Study NCT ID:
NCT01592292
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent
Status:
COMPLETED
Status Verified Date:
2016-03
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 prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.
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?: