Clinical Trials Directory

Trials / Completed

CompletedNCT00030966

Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,200 (actual)
Sponsor
Biogen · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Conditions

Interventions

TypeNameDescription
DRUGNatalizumabNatalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
DRUGPlaceboPlacebo monthly infusion for up to 116 weeks.

Timeline

Start date
2002-01-01
Primary completion
2005-04-01
Completion
2005-12-01
First posted
2002-02-18
Last updated
2009-06-18

Locations

88 sites across 7 countries: United States, Austria, Belgium, France, Germany, Israel, Italy

Source: ClinicalTrials.gov record NCT00030966. Inclusion in this directory is not an endorsement.