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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Natalizumab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Michael Panzara, MD, MPH, Study Director, Affiliation: Biogen
Chris Polman, MD, Principal Investigator, Affiliation: VU Medical Centre

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.

Clinical Details

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

Primary outcome: 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: Reduction in MRI changes and clinical relapses

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Algemeen Ziekenhuis St. Jan, Brugge 8000, Belgium

LUC- University Centre, Diepenbeek 3590, Belgium

National MS Centrum, Melsbroek 1820, Belgium

MS Research Unit, Center for Clinical Research, Halifax B3H 1V7, Canada

Family Medical Centre, Ottawa K1N 5C7, Canada

Faculty Hospital Brno Bohunice, Brno 60200, Czech Republic

Faculty Hospital St. Anne, Brno 656 91, Czech Republic

Faculty Hospital of Hradec Kralove, Hradec Kralove 500 05, Czech Republic

Faculty Hospital Olomouc, Olomouc 775 20, Czech Republic

Faculty Hospital Of Ostrava Poruba, Ostrava 70852, Czech Republic

Hospital Pardubice - Department of Neurology, Pardubice 532 03, Czech Republic

Faculty Hospital Plzen - Clinic of Neurology, Plzen 304 60, Czech Republic

Faculty Hospital Motol - Neurological Clinic, Prague 5 105 06, Czech Republic

General Teaching Hospital - Neurological Department, Prague 2 12802, Czech Republic

Hopital de la Timone, Service de Neurologie, Marseille 13385, France

CHRU - Hopital de Pontchaillou, Service de Neurologie, Rennes 35033, France

St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum, Bochurn 44791, Germany

Klinika Neurologii, Bydgoszcz 85-681, Germany

Academisch Ziekenhuis VU, Amsterdam 1081 HV, Netherlands

Oldchurch Hospital, Essex NE1 4LP, United Kingdom

Ipswich Hospital NHS Trust - Department of Clinical Neurology, Ipswich IP4 5PD, United Kingdom

St. James University Hospital, Department of Neurology, Leeds LS9 7TF, United Kingdom

Guy's Hospital, London SE1 9RT, United Kingdom

King's College Hospital, London SE5 9RS, United Kingdom

Kings College Hospital, Kings Neuroscience Center, London SE5 9RS, United Kingdom

Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, United Kingdom

The Radcliffe Infirmary, University Department of Clinical Neurology, Oxford OX2 0HE, United Kingdom

Royal Hallamshire Hospital, Sheffield S10 2JF, United Kingdom

North Staffordshire Royal Infirmary - Neurology Department, Stoke on Trent ST4 7LN, United Kingdom

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States

Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group, Vancouver, British Columbia V6T 2B5, Canada

East Bay Region Associates in Neurology, Berkeley, California 94705, United States

UC Davis School of Medicine, Department of Neurology, Davis, California 95817-2307, United States

Yale University School of Medicine, Department of Neurology, New Haven, Connecticut 06510, United States

University of Miami School of Medicine, Department of Neurology, Miami, Florida 33136, United States

University of Kansas Medical Center, Department of Neurology, Kansas City, Kansas 66160, United States

Institute of Neurology, Queen Square, London WC1N 3BG, United Kingdom

The Royal London Hospital, Whitechapel, London E1 1BB, United Kingdom

Atkin's Morely Hospital, Wimbledon, London SW20 0NE, United Kingdom

Health Services Centre, Winnipeg, Manitoba R3A 1R9, Canada

Michigan Institute for Neurological Disorders, Farmington Hills, Michigan 48335, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Gimbel MS Center, Teaneck, New Jersey 07666, United States

CMRRC, Albuquerque, New Mexico 87131, United States

Kingston General Hospital, Neurology, Kingston, Ontario K7L 2V7, Canada

University Hospital, London, Ontario N6A 5A5, Canada

Sunnybrook and Women's College and Health Science Centre, Toronto, Ontario M4N 3M5, Canada

University of Toronto, MS Clinic, St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada

Oregon Health Sciences University, Department of Neurology, Portland, Oregon 97201-3098, United States

Lehigh Valley Hospital, Neurosciences Research, Allentown, Pennsylvania 18103, United States

CHVO Hull Hospital, Quebec City, Quebec J8Y 1W7, Canada

Texas Neurology, Dallas, Texas 75214, United States

University of Washington MS Research Center, Seattle, Washington 98195, United States

Additional Information

The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers

MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen.

Starting date: November 2001
Last updated: June 15, 2009

Page last updated: August 23, 2015

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