Clinical trial NCT00030966: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
MS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2002-02-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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.
timeFrame: 1 year and 2 years
Secondary outcomes:
measure: If this combination reduces MRI lesions and the overall rate of clinical relapses
timeFrame: 1 year and 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham, Department of Neurology
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Neurological Associates, Ltd.
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
city: Irvine
country: United States
facility: University of California - Irvine
state: California
city: Los Angeles
country: United States
facility: USC MS Comprehensive Care Center
state: California
city: Redwood City
country: United States
facility: Kaiser-Permanente Medical Center
state: California
city: San Francisco
country: United States
facility: MS Center at UCSF
state: California
city: Colorado Springs
country: United States
facility: Healthsouth Rehabilitation Hospital
state: Colorado
city: Denver
country: United States
facility: University of Colorado MS Center
state: Colorado
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
city: Washington
country: United States
facility: Georgetown Univesity Hospital, Research Pharmacy
state: District of Columbia
city: Washington
country: United States
facility: George Washington University MS Center
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: North Ridge NeuroScience Center
state: Florida
city: Maitland
country: United States
facility: Maitland Neurology
state: Florida
city: Miami
country: United States
facility: University of Miami, Department of Neurology
state: Florida
city: Atlanta
country: United States
facility: The Multiple Sclerosis Center of Atlanta
state: Georgia
city: Marietta
country: United States
facility: Marietta Neurological Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern University, Department of Neurology
state: Illinois
city: Chicago
country: United States
facility: Rush-Presbyterian St. Luke's Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Center for Clinical Research
state: Illinois
city: Maywood
country: United States
facility: Loyola Medical Center
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology Northbrook
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Neuroscience Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Outpatient Pharmacy
state: Iowa
city: New Orleans
country: United States
facility: LSU Neurolgoy Clinic in New Orleans
state: Louisiana
city: Scarborough
country: United States
facility: Maine Neurology
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Hospital, Department of Neurology
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University MS Clinic
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders
state: Michigan
city: Minneapolis
country: United States
facility: Noran Neurological Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Teaneck
country: United States
facility: Bernard W. Gimbel MS Center
state: New Jersey
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center, Division of Neurology
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital, Department of Neurology
state: New York
city: New York
country: United States
facility: MS Care Center
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital, MS Research & Treatment Center
state: New York
city: New York
country: United States
facility: New York Hospital - Cornell Medical Center
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institution
state: New York
city: Rochester
country: United States
facility: Strong Health Pharmacy Services
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Stony Brook
country: United States
facility: University Hospital at Stony Brook
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: MS Center at Carolinas Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine, Department of Neurology
state: North Carolina
city: Cincinnati
country: United States
facility: Riverhills Neurology
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Greenstein Neurology Associates & MS Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Department of Neurology
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee - Memphis
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Option Care Infusion
state: Texas
city: Dallas
country: United States
facility: UTSW Medical School
state: Texas
city: Houston
country: United States
facility: Baylor Methodist International MS Center
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health Sciences
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates, Inc.
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: MS Research Center
state: Washington
city: Milwaukee
country: United States
facility: St. Francis Hospital, Center for Neurological Disorders
state: Wisconsin
city: Graz
country: Austria
facility: Universitatsklinik fur Neurologie
city: Innsbruck
country: Austria
facility: Universitatsklinik fur Neurologie
city: Brussels
country: Belgium
facility: Hopital Universitaire U.L.B. Erasme
city: Sijsele
country: Belgium
facility: Elisabeth Ziekenhuis
city: Bordeaux
country: France
facility: Hopital Pellegrin Tripode, Neurologie
city: Lyon
country: France
facility: Hopital neurologique Pierre Werth
city: Berlin
country: Germany
facility: Judisches Krankenhaus
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen, Oberarzt Neurologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Neurologische Klinik
city: Henningsdorf
country: Germany
facility: Neurologische Abteilung
city: Osnabrück
country: Germany
facility: Städtische Kliniken Osnabrück
city: Seesen/Harz
country: Germany
facility: Asklepios Klinik Schildautal
city: Wiesbaden
country: Germany
facility: Fachbereich Neurologie und Klinische Neurophysiologie
city: Jerusalem
country: Israel
facility: Hadassah Hebrew Uni Hospital, Department of Neurology
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, MS Center
city: Genova
country: Italy
facility: Universita di Genova, Clinica Neurologica
Study officials:
affiliation: Biogen
name: Michael Panzara, MD, MPH
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Richard A Rudick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.