Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083759
Status:
TERMINATED
Last Update Posted:
2016-07-18
First Post:
2004-06-01
Brief Title:
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase II Multicenter Double-blind Placebo-Controlled Study of the Efficacy Safety and Tolerability of Intravenous Natalizumab 300 mg in Subjects With Moderate to Severe Rheumatoid Arthritis RA Receiving Concomitant Treatment With Methotrexate MTX
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The biological effect seen with natalizumab was not sufficient to warrant further development in RA
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis RA receiving concomitant treatment with methotrexate MTX It is thought that natalizumab may stop the movement of certain white blood cells known as lymphocytes into joint tissue These cells are thought to cause damage in the joints leading to the symptoms of RA
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