Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00424502
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2007-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
Status:
COMPLETED
Status Verified Date:
2016-04
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 single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
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?: