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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030966
• Other study ID #: C-1802
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2002
• Last updated: June 17, 2009
• Start date: January 2002
• Est. completion date: December 2005

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Natalizumab
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
• Placebo
Placebo monthly infusion for up to 116 weeks.

Locations

Country	Name	City	State
Austria	Universitatsklinik fur Neurologie	Graz
Austria	Universitatsklinik fur Neurologie	Innsbruck
Belgium	Hopital Universitaire U.L.B. Erasme	Brussels
Belgium	Elisabeth Ziekenhuis	Sijsele
France	Hopital Pellegrin Tripode, Neurologie	Bordeaux
France	Hopital neurologique Pierre Werth	Lyon
Germany	Judisches Krankenhaus	Berlin
Germany	Universitaetsklinikum Giessen, Oberarzt Neurologie	Giessen
Germany	Medizinische Hochschule Hannover, Neurologische Klinik	Hannover
Germany	Neurologische Abteilung	Henningsdorf
Germany	Städtische Kliniken Osnabrück	Osnabrück
Germany	Asklepios Klinik Schildautal	Seesen/Harz
Germany	Fachbereich Neurologie und Klinische Neurophysiologie	Wiesbaden
Israel	Hadassah Hebrew Uni Hospital, Department of Neurology	Jerusalem
Israel	Sheba Medical Center, MS Center	Tel Hashomer
Italy	Universita di Genova, Clinica Neurologica	Genova
United States	Albany Medical Center	Albany	New York
United States	Upstate Clinical Research, LLC	Albany	New York
United States	The Multiple Sclerosis Center of Atlanta	Atlanta	Georgia
United States	University of Maryland Hospital, Department of Neurology	Baltimore	Maryland
United States	University of Alabama-Birmingham, Department of Neurology	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Maimonides Medical Center, Division of Neurology	Brooklyn	New York
United States	Buffalo General Hospital, Department of Neurology	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	MS Center at Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Health Sciences	Charlottesville	Virginia
United States	Northwestern University, Department of Neurology	Chicago	Illinois
United States	Rush-Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	Riverhills Neurology	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Healthsouth Rehabilitation Hospital	Colorado Springs	Colorado
United States	Option Care Infusion	Dallas	Texas
United States	UTSW Medical School	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	University of Colorado MS Center	Denver	Colorado
United States	Griffin Hospital	Derby	Connecticut
United States	Mercy Hospital Outpatient Pharmacy	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	Michigan State University MS Clinic	East Lansing	Michigan
United States	Alexian Brothers Center for Clinical Research	Elk Grove Village	Illinois
United States	Michigan Institute for Neurological Disorders	Farmington Hills	Michigan
United States	North Ridge NeuroScience Center	Ft. Lauderdale	Florida
United States	Baylor Methodist International MS Center	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of California - Irvine	Irvine	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas
United States	USC MS Comprehensive Care Center	Los Angeles	California
United States	Maitland Neurology	Maitland	Florida
United States	Marietta Neurological Associates	Marietta	Georgia
United States	Loyola Medical Center	Maywood	Illinois
United States	University of Tennessee - Memphis	Memphis	Tennessee
United States	University of Miami, Department of Neurology	Miami	Florida
United States	St. Francis Hospital, Center for Neurological Disorders	Milwaukee	Wisconsin
United States	Noran Neurological Clinic	Minneapolis	Minnesota
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	LSU Neurolgoy Clinic in New Orleans	New Orleans	Louisiana
United States	MS Care Center	New York	New York
United States	New York Hospital - Cornell Medical Center	New York	New York
United States	New York State Psychiatric Institution	New York	New York
United States	St. Luke's Roosevelt Hospital, MS Research & Treatment Center	New York	New York
United States	Consultants in Neurology Northbrook	Northbrook	Illinois
United States	Greenstein Neurology Associates & MS Institute	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Phoenix Neurological Associates, Ltd.	Phoenix	Arizona
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	University of Pittsburgh, Department of Neurology	Pittsburgh	Pennsylvania
United States	Providence Saint Vincent Medical Center	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Kaiser-Permanente Medical Center	Redwood City	California
United States	Neurological Associates, Inc.	Richmond	Virginia
United States	Strong Health Pharmacy Services	Rochester	New York
United States	Central Texas Neurology	Round Rock	Texas
United States	MS Center at UCSF	San Francisco	California
United States	Maine Neurology	Scarborough	Maine
United States	MS Research Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Springfield Clinic Neuroscience Institute	Springfield	Illinois
United States	St. John's Mercy Medical Center	St. Louis	Missouri
United States	Staten Island University Hospital	Staten Island	New York
United States	University Hospital at Stony Brook	Stony Brook	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Bernard W. Gimbel MS Center	Teaneck	New Jersey
United States	George Washington University MS Center	Washington	District of Columbia
United States	Georgetown Univesity Hospital, Research Pharmacy	Washington	District of Columbia
United States	Wake Forest University School of Medicine, Department of Neurology	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Countries where clinical trial is conducted

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

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	If this combination reduces MRI lesions and the overall rate of clinical relapses		1 year and 2 years	No

External Links

•   MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen.
•   The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers.