Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00027300

Collaborator

Elan Pharmaceuticals (Industry)

900

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Nov 1, 2004

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Natalizumab 300 mg, IV	Drug: Natalizumab Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks. Other Names: Tysabri
Placebo Comparator: Group 2 Placebo IV infusion	Drug: Placebo Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Arm

Intervention/Treatment

Experimental: Group 1

Natalizumab 300 mg, IV

Drug: Natalizumab

Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.

Other Names:

Tysabri

Placebo Comparator: Group 2

Placebo IV infusion

Drug: Placebo

Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Outcome Measures

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. [1 year and 2 years]

Secondary Outcome Measures

Reduction in MRI changes and clinical relapses [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259
2	East Bay Region Associates in Neurology	Berkeley	California	United States	94705
3	UC Davis School of Medicine, Department of Neurology	Davis	California	United States	95817-2307
4	Yale University School of Medicine, Department of Neurology	New Haven	Connecticut	United States	06510
5	University of Miami School of Medicine, Department of Neurology	Miami	Florida	United States	33136
6	University of Kansas Medical Center, Department of Neurology	Kansas City	Kansas	United States	66160
7	Michigan Institute for Neurological Disorders	Farmington Hills	Michigan	United States	48335
8	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
9	Gimbel MS Center	Teaneck	New Jersey	United States	07666
10	CMRRC	Albuquerque	New Mexico	United States	87131
11	Oregon Health Sciences University, Department of Neurology	Portland	Oregon	United States	97201-3098
12	Lehigh Valley Hospital, Neurosciences Research	Allentown	Pennsylvania	United States	18103
13	Texas Neurology	Dallas	Texas	United States	75214
14	University of Washington MS Research Center	Seattle	Washington	United States	98195
15	Algemeen Ziekenhuis St. Jan	Brugge		Belgium	8000
16	LUC- University Centre	Diepenbeek		Belgium	3590
17	National MS Centrum	Melsbroek		Belgium	1820
18	Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group	Vancouver	British Columbia	Canada	V6T 2B5
19	Health Services Centre	Winnipeg	Manitoba	Canada	R3A 1R9
20	Kingston General Hospital, Neurology	Kingston	Ontario	Canada	K7L 2V7
21	University Hospital	London	Ontario	Canada	N6A 5A5
22	Sunnybrook and Women's College and Health Science Centre	Toronto	Ontario	Canada	M4N 3M5
23	University of Toronto, MS Clinic, St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
24	CHVO Hull Hospital	Quebec City	Quebec	Canada	J8Y 1W7
25	MS Research Unit, Center for Clinical Research	Halifax		Canada	B3H 1V7
26	Family Medical Centre	Ottawa		Canada	K1N 5C7
27	Faculty Hospital Brno Bohunice	Brno		Czech Republic	60200
28	Faculty Hospital St. Anne	Brno		Czech Republic	656 91
29	Faculty Hospital of Hradec Kralove	Hradec Kralove		Czech Republic	500 05
30	Faculty Hospital Olomouc	Olomouc		Czech Republic	775 20
31	Faculty Hospital Of Ostrava Poruba	Ostrava		Czech Republic	70852
32	Hospital Pardubice - Department of Neurology	Pardubice		Czech Republic	532 03
33	Faculty Hospital Plzen - Clinic of Neurology	Plzen		Czech Republic	304 60
34	General Teaching Hospital - Neurological Department	Prague		Czech Republic	2 12802
35	Faculty Hospital Motol - Neurological Clinic	Prague		Czech Republic	5 105 06
36	Hopital de la Timone, Service de Neurologie	Marseille		France	13385
37	CHRU - Hopital de Pontchaillou, Service de Neurologie	Rennes		France	35033
38	St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum	Bochurn		Germany	44791
39	Klinika Neurologii	Bydgoszcz		Germany	85-681
40	Academisch Ziekenhuis VU	Amsterdam		Netherlands	1081 HV
41	Institute of Neurology	Queen Square	London	United Kingdom	WC1N 3BG
42	The Royal London Hospital	Whitechapel	London	United Kingdom	E1 1BB
43	Atkin's Morely Hospital	Wimbledon	London	United Kingdom	SW20 0NE
44	Oldchurch Hospital	Essex		United Kingdom	NE1 4LP
45	Ipswich Hospital NHS Trust - Department of Clinical Neurology	Ipswich		United Kingdom	IP4 5PD
46	St. James University Hospital, Department of Neurology	Leeds		United Kingdom	LS9 7TF
47	Guy's Hospital	London		United Kingdom	SE1 9RT
48	King's College Hospital	London		United Kingdom	SE5 9RS
49	Kings College Hospital, Kings Neuroscience Center	London		United Kingdom	SE5 9RS
50	Royal Victoria Infirmary	Newcastle upon Tyne		United Kingdom	NE1 4LP
51	The Radcliffe Infirmary, University Department of Clinical Neurology	Oxford		United Kingdom	OX2 0HE
52	Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF
53	North Staffordshire Royal Infirmary - Neurology Department	Stoke on Trent		United Kingdom	ST4 7LN