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

Phase 3

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Natalizumab; Drug: Placebo

• Registration Number: NCT00030966
• Lead Sponsor: Biogen

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2002-02-15
• Study First Submitted QC: 2002-02-15
• Study First Posted: 2002-02-18
• Primary Completion: 2005-04
• Study Completion: 2005-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-17
• Last Update Posted: 2009-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4
• Between the ages of 18 and 55, inclusive
• Baseline EDSS score between 0.0 and 5.0, inclusive
• Have been treated with Avonex for at least the 12 months prior to randomization
• Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
• Cranial MRI scan demonstrating lesions consistent with MS.
• Have given written informed consent to participate in the study.

Exclusion Criteria

• Primary progressive, secondary progressive, or progressive relapsing MS.
• MS relapse has occurred within 50 days of randomization
• A clinically significant infectious illness within 30 days prior to randomization
• History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3
• Abnormal blood tests at Screening Visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Natalizumab	Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
Group 2	Placebo	Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.

Primary Outcome Measures

Name	Time	Method
Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.	1 year and 2 years

Secondary Outcome Measures

Name	Time	Method
If this combination reduces MRI lesions and the overall rate of clinical relapses	1 year and 2 years

Trial Locations

Locations (87)

University of Alabama-Birmingham, Department of Neurology; 🇺🇸 Birmingham, Alabama, United States

Phoenix Neurological Associates, Ltd.; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas For Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of California - Irvine; 🇺🇸 Irvine, California, United States

USC MS Comprehensive Care Center; 🇺🇸 Los Angeles, California, United States

Kaiser-Permanente Medical Center; 🇺🇸 Redwood City, California, United States

MS Center at UCSF; 🇺🇸 San Francisco, California, United States

Healthsouth Rehabilitation Hospital; 🇺🇸 Colorado Springs, Colorado, United States

University of Colorado MS Center; 🇺🇸 Denver, Colorado, United States

Griffin Hospital; 🇺🇸 Derby, Connecticut, United States

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