Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422942
Status:
TERMINATED
Last Update Posted:
2014-07-16
First Post:
2007-01-15
Brief Title:
A Pharmacokinetic and Pharmacodynamic Study of MabThera Rituximab Plus Methotrexate in Patients With Rheumatoid Arthritis RA
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated after enrollment of 3 participants due to recruitment difficulties
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 investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA after MabThera 1000mg iv x 2 on days 1 and 15 methotrexate 10-25mgweek po treatment The clinical efficacy and pharmacokinetic profile of MabThera after treatment and retreatment will also be investigated The anticipated time on study treatment is 2 years and the target sample size is 100 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