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Safety and Efficacy of Natalizumab 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 Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001) Between the ages of 18 and 50, inclusive. Baseline EDSS score between 0.0 and 5.0, inclusive. Have experienced at least one relapse within the 12 months prior to randomization. Cranial MRI scan demonstrating lesion(s) 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,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse. A clinically significant infectious illness within 30 days prior to randomization. History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent 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 performed at the Screening Visit.

Sites / Locations

  • Mayo Clinic Scottsdale
  • East Bay Region Associates in Neurology
  • UC Davis School of Medicine, Department of Neurology
  • Yale University School of Medicine, Department of Neurology
  • University of Miami School of Medicine, Department of Neurology
  • University of Kansas Medical Center, Department of Neurology
  • Michigan Institute for Neurological Disorders
  • University of Nebraska Medical Center
  • Gimbel MS Center
  • CMRRC
  • Oregon Health Sciences University, Department of Neurology
  • Lehigh Valley Hospital, Neurosciences Research
  • Texas Neurology
  • University of Washington MS Research Center
  • Algemeen Ziekenhuis St. Jan
  • LUC- University Centre
  • National MS Centrum
  • Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
  • Health Services Centre
  • Kingston General Hospital, Neurology
  • University Hospital
  • Sunnybrook and Women's College and Health Science Centre
  • University of Toronto, MS Clinic, St. Michael's Hospital
  • CHVO Hull Hospital
  • MS Research Unit, Center for Clinical Research
  • Family Medical Centre
  • Faculty Hospital Brno Bohunice
  • Faculty Hospital St. Anne
  • Faculty Hospital of Hradec Kralove
  • Faculty Hospital Olomouc
  • Faculty Hospital Of Ostrava Poruba
  • Hospital Pardubice - Department of Neurology
  • Faculty Hospital Plzen - Clinic of Neurology
  • General Teaching Hospital - Neurological Department
  • Faculty Hospital Motol - Neurological Clinic
  • Hopital de la Timone, Service de Neurologie
  • CHRU - Hopital de Pontchaillou, Service de Neurologie
  • St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
  • Klinika Neurologii
  • Academisch Ziekenhuis VU
  • Institute of Neurology
  • The Royal London Hospital
  • Atkin's Morely Hospital
  • Oldchurch Hospital
  • Ipswich Hospital NHS Trust - Department of Clinical Neurology
  • St. James University Hospital, Department of Neurology
  • Guy's Hospital
  • King's College Hospital
  • Kings College Hospital, Kings Neuroscience Center
  • Royal Victoria Infirmary
  • The Radcliffe Infirmary, University Department of Clinical Neurology
  • Royal Hallamshire Hospital
  • North Staffordshire Royal Infirmary - Neurology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Natalizumab 300 mg, IV

Placebo IV infusion

Outcomes

Primary Outcome Measures

The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years.

Secondary Outcome Measures

Reduction in MRI changes and clinical relapses

Full Information

First Posted
November 30, 2001
Last Updated
January 5, 2017
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00027300
Brief Title
Safety and Efficacy of Natalizumab 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 in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
January 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 the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in 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
Relapsing Remitting Multiple Sclerosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Natalizumab 300 mg, IV
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo IV infusion
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Other Intervention Name(s)
Tysabri
Intervention Description
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
Primary Outcome Measure Information:
Title
The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years.
Time Frame
1 year and 2 years
Secondary Outcome Measure Information:
Title
Reduction in MRI changes and clinical relapses
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001) Between the ages of 18 and 50, inclusive. Baseline EDSS score between 0.0 and 5.0, inclusive. Have experienced at least one relapse within the 12 months prior to randomization. Cranial MRI scan demonstrating lesion(s) 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,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse. A clinically significant infectious illness within 30 days prior to randomization. History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent 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 performed at the 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
Chris Polman, MD
Organizational Affiliation
VU Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
East Bay Region Associates in Neurology
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
UC Davis School of Medicine, Department of Neurology
City
Davis
State/Province
California
ZIP/Postal Code
95817-2307
Country
United States
Facility Name
Yale University School of Medicine, Department of Neurology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Miami School of Medicine, Department of Neurology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Kansas Medical Center, Department of Neurology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Michigan Institute for Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48335
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Gimbel MS Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
CMRRC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Oregon Health Sciences University, Department of Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Lehigh Valley Hospital, Neurosciences Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Texas Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
University of Washington MS Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Algemeen Ziekenhuis St. Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
LUC- University Centre
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Facility Name
National MS Centrum
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Health Services Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Kingston General Hospital, Neurology
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Sunnybrook and Women's College and Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University of Toronto, MS Clinic, St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
CHVO Hull Hospital
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
J8Y 1W7
Country
Canada
Facility Name
MS Research Unit, Center for Clinical Research
City
Halifax
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Family Medical Centre
City
Ottawa
ZIP/Postal Code
K1N 5C7
Country
Canada
Facility Name
Faculty Hospital Brno Bohunice
City
Brno
ZIP/Postal Code
60200
Country
Czech Republic
Facility Name
Faculty Hospital St. Anne
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
Faculty Hospital of Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Faculty Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Faculty Hospital Of Ostrava Poruba
City
Ostrava
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Hospital Pardubice - Department of Neurology
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
Faculty Hospital Plzen - Clinic of Neurology
City
Plzen
ZIP/Postal Code
304 60
Country
Czech Republic
Facility Name
General Teaching Hospital - Neurological Department
City
Prague
ZIP/Postal Code
2 12802
Country
Czech Republic
Facility Name
Faculty Hospital Motol - Neurological Clinic
City
Prague
ZIP/Postal Code
5 105 06
Country
Czech Republic
Facility Name
Hopital de la Timone, Service de Neurologie
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHRU - Hopital de Pontchaillou, Service de Neurologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
City
Bochurn
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinika Neurologii
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Germany
Facility Name
Academisch Ziekenhuis VU
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Institute of Neurology
City
Queen Square
State/Province
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
The Royal London Hospital
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Atkin's Morely Hospital
City
Wimbledon
State/Province
London
ZIP/Postal Code
SW20 0NE
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Essex
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Ipswich Hospital NHS Trust - Department of Clinical Neurology
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
St. James University Hospital, Department of Neurology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Kings College Hospital, Kings Neuroscience Center
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
The Radcliffe Infirmary, University Department of Clinical Neurology
City
Oxford
ZIP/Postal Code
OX2 0HE
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
North Staffordshire Royal Infirmary - Neurology Department
City
Stoke on Trent
ZIP/Postal Code
ST4 7LN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25511792
Citation
Voloshyna N, Havrdova E, Hutchinson M, Nehrych T, You X, Belachew S, Hotermans C, Paes D. Natalizumab improves ambulation in relapsing-remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM. Eur J Neurol. 2015 Mar;22(3):570-7. doi: 10.1111/ene.12618. Epub 2014 Dec 15.
Results Reference
background
PubMed Identifier
16510744
Citation
Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. doi: 10.1056/NEJMoa044397.
Results Reference
result
PubMed Identifier
22521274
Citation
Balcer LJ, Galetta SL, Polman CH, Eggenberger E, Calabresi PA, Zhang A, Scanlon JV, Hyde R. Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab in relapsing MS. J Neurol Sci. 2012 Jul 15;318(1-2):119-24. doi: 10.1016/j.jns.2012.03.009. Epub 2012 Apr 21.
Results Reference
derived
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 the Treatment of Multiple Sclerosis

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