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

NCT00030966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2009-06-18

No results posted yet for this study

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

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Natalizumab

Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.

DRUG

Placebo

Placebo monthly infusion for up to 116 weeks.

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Michael Panzara, MD, MPH · Biogen

  • Richard A Rudick, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2005-04-30
Completion
2005-12-31

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00030966 on ClinicalTrials.gov