NCT00083759

Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	natalizumab
DRUG	placebo

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-02-01
• First posted: 2004-06-03
• Last updated: 2016-07-18
• Results posted: 2009-06-02

Locations

12 sites across 2 countries: United States, Canada