Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-03-09 @ 9:20 AM
Study NCT ID:
NCT00083759
Status:
TERMINATED
Last Update Posted:
2016-07-18
First Post:
2004-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
Sponsor:
Biogen
Organization:
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:
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?: