Natalizumab Re-Initiation of Dosing

This study has been completed.
Elan Pharmaceuticals
Information provided by:
Biogen Idec Identifier:
First received: January 31, 2006
Last updated: December 20, 2009
Last verified: December 2009

The purpose of this study is to evaluate the safety of natalizumab (TYSABRI®) monotherapy following re-exposure to natalizumab. This includes assessing the risk of hypersensitivity, immunogenicity, and infection, and confirming the safety of switching from interferon-beta, glatiramer acetate, or other multiple sclerosis therapies to natalizumab.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Natalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation

Resource links provided by NLM:

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of Subjects With Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Hypersensitivity-Related Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Persistent Antibodies to Natalizumab [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 404
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open Label 300 mg IV Natalizumab
Drug: Natalizumab
300 mg IV monthly for up to 48 weeks
Other Name: Tysabri

Detailed Description:

Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial patients in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760). This study included patients in North America. In parallel with the conduct of this study, a similar study, 101-MS-321 (NCT 00297232) was initiated for patients in Europe and the rest of the world. The primary purpose and primary outcome for both studies were identical, therefore, the combined data from both studies are presented.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MS subjects who completed Study C-1801, C-1802, or C-1803 and completed a Dosing Suspension Safety Evaluation (neurological examination and MRI scan)
  • Considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 [NCT000276172] may be used)
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment
  • History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its identifier: NCT00306592

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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35233
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006
Research Site
Scottsdale, Arizona, United States, 85259
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Berkeley, California, United States, 94705
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Los Angeles, California, United States, 90033
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Redwood City, California, United States, 94063
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Sacramento, California, United States, 95817
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San Francisco, California, United States, 94117
United States, Colorado
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Colorado Springs, Colorado, United States, 80919
United States, Connecticut
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New Haven, Connecticut, United States, 06510
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, Florida
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Maitland, Florida, United States, 32751
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Miami, Florida, United States, 33136
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Pompano Beach, Florida, United States, 33060
United States, Georgia
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Atlanta, Georgia, United States, 30327
United States, Illinois
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612
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Elk Grove Village, Illinois, United States, 60007
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Northbrook, Illinois, United States, 60062
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Kansas
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Kansas City, Kansas, United States, 66160
United States, Maryland
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Baltimore, Maryland, United States, 21201
United States, Massachusetts
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Brookline, Massachusetts, United States, 02445
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Worcester, Massachusetts, United States, 01655
United States, Michigan
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East Lansing, Michigan, United States, 48824
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Farmington Hills, Michigan, United States, 48334
United States, New Jersey
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Teaneck, New Jersey, United States, 07666
United States, New Mexico
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Albuquerque, New Mexico, United States, 87131
United States, New York
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Buffalo, New York, United States, 14203
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New York, New York, United States, 10319
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New York, New York, United States, 10003
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Staten Island, New York, United States, 10305
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Syracuse, New York, United States, 13202
United States, North Carolina
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Charlotte, North Carolina, United States, 28207
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Raleigh, North Carolina, United States, 27607
United States, North Dakota
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Fargo, North Dakota, United States, 58103
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44195
United States, Oregon
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Portland, Oregon, United States, 97225
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18103
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Philadelphia, Pennsylvania, United States, 19146
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15212
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Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
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Memphis, Tennessee, United States, 38163
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Nashville, Tennessee, United States, 37215
United States, Texas
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Dallas, Texas, United States, 75214
Research Site
Round Rock, Texas, United States, 78681
United States, Vermont
Research Site
Burlington, Vermont, United States, 05401
United States, Virginia
Research Site
Charlottesville, Virginia, United States, 22903
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V6T2B5
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H1V7
Canada, Ontario
Research Site
Kingston, Ontario, Canada, K7L2V7
Research Site
London, Ontario, Canada, N6A5A5
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Ottawa, Ontario, Canada, K2G6E2
Research Site
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
Research Site
Gatineau, Quebec, Canada, J8Y1W7
Research Site
Greenfield Park, Quebec, Canada, J4V2H1
Research Site
Montreal, Quebec, Canada, H3A2B4
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc. Identifier: NCT00306592     History of Changes
Other Study ID Numbers: 101-MS-322
Study First Received: January 31, 2006
Results First Received: June 30, 2009
Last Updated: December 20, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Biogen Idec:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes processed this record on April 17, 2014