Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Placebo
- Registration Number
- NCT00027300
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Natalizumab Natalizumab 300 mg, IV Group 2 Placebo Placebo IV infusion
- Primary Outcome Measures
Name Time Method 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. 1 year and 2 years
- Secondary Outcome Measures
Name Time Method Reduction in MRI changes and clinical relapses 1 year
Trial Locations
- Locations (53)
Oldchurch Hospital
π¬π§Essex, United Kingdom
National MS Centrum
π§πͺMelsbroek, Belgium
University of Miami School of Medicine, Department of Neurology
πΊπΈMiami, Florida, United States
Michigan Institute for Neurological Disorders
πΊπΈFarmington Hills, Michigan, United States
Algemeen Ziekenhuis St. Jan
π§πͺBrugge, Belgium
CMRRC
πΊπΈAlbuquerque, New Mexico, United States
CHVO Hull Hospital
π¨π¦Quebec City, Quebec, Canada
Mayo Clinic Scottsdale
πΊπΈScottsdale, Arizona, United States
MS Research Unit, Center for Clinical Research
π¨π¦Halifax, Canada
Oregon Health Sciences University, Department of Neurology
πΊπΈPortland, Oregon, United States
Health Services Centre
π¨π¦Winnipeg, Manitoba, Canada
Kingston General Hospital, Neurology
π¨π¦Kingston, Ontario, Canada
LUC- University Centre
π§πͺDiepenbeek, Belgium
Family Medical Centre
π¨π¦Ottawa, Canada
East Bay Region Associates in Neurology
πΊπΈBerkeley, California, United States
UC Davis School of Medicine, Department of Neurology
πΊπΈDavis, California, United States
Royal Hallamshire Hospital
π¬π§Sheffield, United Kingdom
University of Toronto, MS Clinic, St. Michael's Hospital
π¨π¦Toronto, Ontario, Canada
St. James University Hospital, Department of Neurology
π¬π§Leeds, United Kingdom
Ipswich Hospital NHS Trust - Department of Clinical Neurology
π¬π§Ipswich, United Kingdom
Royal Victoria Infirmary
π¬π§Newcastle upon Tyne, United Kingdom
The Radcliffe Infirmary, University Department of Clinical Neurology
π¬π§Oxford, United Kingdom
Sunnybrook and Women's College and Health Science Centre
π¨π¦Toronto, Ontario, Canada
King's College Hospital
π¬π§London, United Kingdom
North Staffordshire Royal Infirmary - Neurology Department
π¬π§Stoke on Trent, United Kingdom
Yale University School of Medicine, Department of Neurology
πΊπΈNew Haven, Connecticut, United States
University of Kansas Medical Center, Department of Neurology
πΊπΈKansas City, Kansas, United States
University of Nebraska Medical Center
πΊπΈOmaha, Nebraska, United States
Gimbel MS Center
πΊπΈTeaneck, New Jersey, United States
University Hospital
π¨π¦London, Ontario, Canada
Faculty Hospital of Hradec Kralove
π¨πΏHradec Kralove, Czech Republic
Faculty Hospital Of Ostrava Poruba
π¨πΏOstrava, Czech Republic
Faculty Hospital Olomouc
π¨πΏOlomouc, Czech Republic
Hospital Pardubice - Department of Neurology
π¨πΏPardubice, Czech Republic
Faculty Hospital Plzen - Clinic of Neurology
π¨πΏPlzen, Czech Republic
Academisch Ziekenhuis VU
π³π±Amsterdam, Netherlands
CHRU - Hopital de Pontchaillou, Service de Neurologie
π«π·Rennes, France
St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
π©πͺBochurn, Germany
Hopital de la Timone, Service de Neurologie
π«π·Marseille, France
Faculty Hospital Motol - Neurological Clinic
π¨πΏPrague, Czech Republic
Klinika Neurologii
π©πͺBydgoszcz, Germany
Institute of Neurology
π¬π§Queen Square, London, United Kingdom
The Royal London Hospital
π¬π§Whitechapel, London, United Kingdom
Atkin's Morely Hospital
π¬π§Wimbledon, London, United Kingdom
Faculty Hospital Brno Bohunice
π¨πΏBrno, Czech Republic
Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
π¨π¦Vancouver, British Columbia, Canada
Faculty Hospital St. Anne
π¨πΏBrno, Czech Republic
General Teaching Hospital - Neurological Department
π¨πΏPrague, Czech Republic
Lehigh Valley Hospital, Neurosciences Research
πΊπΈAllentown, Pennsylvania, United States
Texas Neurology
πΊπΈDallas, Texas, United States
University of Washington MS Research Center
πΊπΈSeattle, Washington, United States
Kings College Hospital, Kings Neuroscience Center
π¬π§London, United Kingdom
Guy's Hospital
π¬π§London, United Kingdom