Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

NCT00083759 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2016-07-18

Study results available
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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

Interventions

DRUG

natalizumab

DRUG

placebo

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY
  • Biogen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2005-02-28

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00083759 on ClinicalTrials.gov