Natalizumab Re-Initiation of Dosing

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00306592
First received: January 31, 2006
Last updated: December 20, 2009
Last verified: December 2009
  Purpose

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
Natalizumab
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00306592

  Hide Study Locations
Locations
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
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Berkeley, California, United States, 94705
Research Site
Los Angeles, California, United States, 90033
Research Site
Redwood City, California, United States, 94063
Research Site
Sacramento, California, United States, 95817
Research Site
San Francisco, California, United States, 94117
United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80919
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site
Maitland, Florida, United States, 32751
Research Site
Miami, Florida, United States, 33136
Research Site
Pompano Beach, Florida, United States, 33060
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30327
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637
Research Site
Chicago, Illinois, United States, 60612
Research Site
Elk Grove Village, Illinois, United States, 60007
Research Site
Northbrook, Illinois, United States, 60062
United States, Iowa
Research Site
Des Moines, Iowa, United States, 50314
United States, Kansas
Research Site
Kansas City, Kansas, United States, 66160
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Research Site
Brookline, Massachusetts, United States, 02445
Research Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
Research Site
East Lansing, Michigan, United States, 48824
Research Site
Farmington Hills, Michigan, United States, 48334
United States, New Jersey
Research Site
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87131
United States, New York
Research Site
Buffalo, New York, United States, 14203
Research Site
New York, New York, United States, 10319
Research Site
New York, New York, United States, 10003
Research Site
Staten Island, New York, United States, 10305
Research Site
Syracuse, New York, United States, 13202
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
Research Site
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Research Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45219
Research Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Research Site
Portland, Oregon, United States, 97225
United States, Pennsylvania
Research Site
Allentown, Pennsylvania, United States, 18103
Research Site
Philadelphia, Pennsylvania, United States, 19146
Research Site
Philadelphia, Pennsylvania, United States, 19104
Research Site
Pittsburgh, Pennsylvania, United States, 15212
Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38163
Research Site
Nashville, Tennessee, United States, 37215
United States, Texas
Research Site
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
Research Site
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
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov 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
MS

Additional relevant MeSH terms:
Multiple Sclerosis
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

ClinicalTrials.gov processed this record on April 17, 2014