Natalizumab Re-Initiation of Dosing

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00306592
First received: January 31, 2006
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: BG00002 (natalizumab)
Phase 3

Study Type: Interventional
Study Design: 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 Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: Yes ]
    AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.

  • Number of Participants With Hypersensitivity-related Adverse Events [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: Yes ]
    For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.

  • Number of Participants With Antibodies to Natalizumab [ Time Frame: Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence) ] [ Designated as safety issue: Yes ]
    'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.


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
Experimental: Natalizumab
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
Biological: BG00002 (natalizumab)
Other Name: Tysabri

Detailed Description:

Study 101-MS-322 (NCT00306592) is conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760). This study includes participants in North America. In parallel with the conduct of this study, a similar study, 101-MS-321 (NCT00297232) is initiated for participants in Europe and the rest of the world. The primary purpose and primary outcome for both studies are identical, therefore, the combined Week 48 data from both studies are presented. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) can enter study 101-MS-321 (NCT 00297232), which is considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592).

  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 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging [MRI] scan)
  • Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arlington, Illinois, United States, 60007
Research Site
Chicago, Illinois, United States, 60637
Research Site
Chicago, Illinois, United States, 60612
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
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
Albany, New York, United States, 12208
Research Site
Buffalo, New York, United States, 14203
Research Site
Great Neck, New York, United States, 10019
Research Site
New York, New York, United States, 10003
Research Site
New York, New York, United States, 10319
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 Center
New York, Ontario, Canada, M4N 3M5
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
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: May 1, 2014
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
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014