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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Natalizumab
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, MS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama-Birmingham, Department of Neurology
  • Phoenix Neurological Associates, Ltd.
  • University of Arkansas For Medical Sciences
  • University of California - Irvine
  • USC MS Comprehensive Care Center
  • Kaiser-Permanente Medical Center
  • MS Center at UCSF
  • Healthsouth Rehabilitation Hospital
  • University of Colorado MS Center
  • Griffin Hospital
  • Georgetown Univesity Hospital, Research Pharmacy
  • George Washington University MS Center
  • North Ridge NeuroScience Center
  • Maitland Neurology
  • University of Miami, Department of Neurology
  • The Multiple Sclerosis Center of Atlanta
  • Marietta Neurological Associates
  • Northwestern University, Department of Neurology
  • Rush-Presbyterian St. Luke's Medical Center
  • Alexian Brothers Center for Clinical Research
  • Loyola Medical Center
  • Consultants in Neurology Northbrook
  • Springfield Clinic Neuroscience Institute
  • Indiana University Medical Center
  • Mercy Hospital Outpatient Pharmacy
  • LSU Neurolgoy Clinic in New Orleans
  • Maine Neurology
  • University of Maryland Hospital, Department of Neurology
  • Brigham and Women's Hospital
  • University of Massachusetts Memorial Medical Center
  • Henry Ford Hospital
  • Michigan State University MS Clinic
  • Michigan Institute for Neurological Disorders
  • Noran Neurological Clinic
  • University of Mississippi Medical Center
  • St. John's Mercy Medical Center
  • Bernard W. Gimbel MS Center
  • Upstate Clinical Research, LLC
  • Albany Medical Center
  • Maimonides Medical Center, Division of Neurology
  • Buffalo General Hospital, Department of Neurology
  • MS Care Center
  • St. Luke's Roosevelt Hospital, MS Research & Treatment Center
  • New York Hospital - Cornell Medical Center
  • New York State Psychiatric Institution
  • Strong Health Pharmacy Services
  • Staten Island University Hospital
  • University Hospital at Stony Brook
  • SUNY Upstate Medical University
  • MS Center at Carolinas Medical Center
  • Raleigh Neurology Associates
  • Wake Forest University School of Medicine, Department of Neurology
  • Riverhills Neurology
  • Cleveland Clinic Foundation
  • Providence Saint Vincent Medical Center
  • Geisinger Medical Center
  • Hospital of the University of Pennsylvania
  • Greenstein Neurology Associates & MS Institute
  • Allegheny Singer Research Institute
  • University of Pittsburgh, Department of Neurology
  • University of Tennessee - Memphis
  • Vanderbilt Medical Center
  • Option Care Infusion
  • UTSW Medical School
  • Baylor Methodist International MS Center
  • Central Texas Neurology
  • Fletcher Allen Health Care
  • University of Virginia Health Sciences
  • Neurological Associates, Inc.
  • Virginia Mason Medical Center
  • MS Research Center
  • St. Francis Hospital, Center for Neurological Disorders
  • Universitatsklinik fur Neurologie
  • Universitatsklinik fur Neurologie
  • Hopital Universitaire U.L.B. Erasme
  • Elisabeth Ziekenhuis
  • Hopital Pellegrin Tripode, Neurologie
  • Hopital neurologique Pierre Werth
  • Judisches Krankenhaus
  • Universitaetsklinikum Giessen, Oberarzt Neurologie
  • Medizinische Hochschule Hannover, Neurologische Klinik
  • Neurologische Abteilung
  • Städtische Kliniken Osnabrück
  • Asklepios Klinik Schildautal
  • Fachbereich Neurologie und Klinische Neurophysiologie
  • Hadassah Hebrew Uni Hospital, Department of Neurology
  • Sheba Medical Center, MS Center
  • Universita di Genova, Clinica Neurologica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.

Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

If this combination reduces MRI lesions and the overall rate of clinical relapses

Full Information

First Posted
February 15, 2002
Last Updated
June 17, 2009
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00030966
Brief Title
Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen
Collaborators
Elan Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis, MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Other Intervention Name(s)
Tysabri
Intervention Description
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo monthly infusion for up to 116 weeks.
Primary Outcome Measure Information:
Title
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.
Time Frame
1 year and 2 years
Secondary Outcome Measure Information:
Title
If this combination reduces MRI lesions and the overall rate of clinical relapses
Time Frame
1 year and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Panzara, MD, MPH
Organizational Affiliation
Biogen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard A Rudick, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama-Birmingham, Department of Neurology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Neurological Associates, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
University of Arkansas For Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
USC MS Comprehensive Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Kaiser-Permanente Medical Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
MS Center at UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Healthsouth Rehabilitation Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
University of Colorado MS Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
Georgetown Univesity Hospital, Research Pharmacy
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington University MS Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
North Ridge NeuroScience Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Maitland Neurology
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami, Department of Neurology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Multiple Sclerosis Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Marietta Neurological Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University, Department of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush-Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Alexian Brothers Center for Clinical Research
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Loyola Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Consultants in Neurology Northbrook
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Springfield Clinic Neuroscience Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mercy Hospital Outpatient Pharmacy
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
LSU Neurolgoy Clinic in New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-8926
Country
United States
Facility Name
University of Maryland Hospital, Department of Neurology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655-0138
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Michigan State University MS Clinic
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Michigan Institute for Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Noran Neurological Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
St. John's Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Bernard W. Gimbel MS Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Maimonides Medical Center, Division of Neurology
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Buffalo General Hospital, Department of Neurology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
MS Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
St. Luke's Roosevelt Hospital, MS Research & Treatment Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Hospital - Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York State Psychiatric Institution
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Strong Health Pharmacy Services
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
University Hospital at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
MS Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest University School of Medicine, Department of Neurology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Riverhills Neurology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Greenstein Neurology Associates & MS Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Allegheny Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh, Department of Neurology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Tennessee - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Option Care Infusion
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
UTSW Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9036
Country
United States
Facility Name
Baylor Methodist International MS Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Neurology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia Health Sciences
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Neurological Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
MS Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
St. Francis Hospital, Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Universitatsklinik fur Neurologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitatsklinik fur Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hopital Universitaire U.L.B. Erasme
City
Brussels
ZIP/Postal Code
1780
Country
Belgium
Facility Name
Elisabeth Ziekenhuis
City
Sijsele
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Hopital Pellegrin Tripode, Neurologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital neurologique Pierre Werth
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Judisches Krankenhaus
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Universitaetsklinikum Giessen, Oberarzt Neurologie
City
Giessen
ZIP/Postal Code
35390
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Neurologische Klinik
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Neurologische Abteilung
City
Henningsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Städtische Kliniken Osnabrück
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Asklepios Klinik Schildautal
City
Seesen/Harz
ZIP/Postal Code
38723
Country
Germany
Facility Name
Fachbereich Neurologie und Klinische Neurophysiologie
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Hadassah Hebrew Uni Hospital, Department of Neurology
City
Jerusalem
Country
Israel
Facility Name
Sheba Medical Center, MS Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Universita di Genova, Clinica Neurologica
City
Genova
ZIP/Postal Code
16132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16510745
Citation
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. doi: 10.1056/NEJMoa044396.
Results Reference
result
Links:
URL
http://www.nationalmssociety.org
Description
The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers.
URL
http://www.msactivesource.com
Description
MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen.

Learn more about this trial

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

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