Natalizumab Re-Initiation of Dosing
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
1 other identifier
interventional
404
2 countries
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
January 26, 2010
CompletedMarch 21, 2017
February 1, 2017
1.8 years
January 31, 2006
June 30, 2009
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
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.
Baseline through Week 48
Number of Participants With Hypersensitivity-related Adverse Events
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.
Baseline through Week 48
Number of Participants With Antibodies to Natalizumab
'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.
Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)
Study Arms (1)
Natalizumab
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (63)
Research Site
Birmingham, Alabama, 35233, United States
Research Site
Phoenix, Arizona, 85006, United States
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Scottsdale, Arizona, 85259, United States
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Little Rock, Arkansas, 72205, United States
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Berkeley, California, 94705, United States
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Los Angeles, California, 90033, United States
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Redwood City, California, 94063, United States
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Sacramento, California, 95817, United States
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San Francisco, California, 94117, United States
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Colorado Springs, Colorado, 80919, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Maitland, Florida, 32751, United States
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Miami, Florida, 33136, United States
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Pompano Beach, Florida, 33060, United States
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Atlanta, Georgia, 30327, United States
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Arlington, Illinois, 60007, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Northbrook, Illinois, 60062, United States
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Des Moines, Iowa, 50314, United States
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Kansas City, Kansas, 66160, United States
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Baltimore, Maryland, 21201, United States
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Worcester, Massachusetts, 01655, United States
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East Lansing, Michigan, 48824, United States
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Farmington Hills, Michigan, 48334, United States
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Teaneck, New Jersey, 07666, United States
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Albuquerque, New Mexico, 87131, United States
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Albany, New York, 12208, United States
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Buffalo, New York, 14203, United States
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Great Neck, New York, 10019, United States
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New York, New York, 10003, United States
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New York, New York, 10319, United States
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Staten Island, New York, 10305, United States
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Syracuse, New York, 13202, United States
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Charlotte, North Carolina, 28207, United States
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Raleigh, North Carolina, 27607, United States
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Fargo, North Dakota, 58103, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97225, United States
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Allentown, Pennsylvania, 18103, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19146, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Memphis, Tennessee, 38163, United States
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Nashville, Tennessee, 37215, United States
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Dallas, Texas, 75214, United States
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Round Rock, Texas, 78681, United States
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Burlington, Vermont, 05401, United States
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Charlottesville, Virginia, 22903, United States
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Milwaukee, Wisconsin, 53215, United States
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Vancouver, British Columbia, V6T2B5, Canada
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Halifax, Nova Scotia, B3H1V7, Canada
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Kingston, Ontario, K7L2V7, Canada
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London, Ontario, N6A5A5, Canada
Research Center
New York, Ontario, M4N 3M5, Canada
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Ottawa, Ontario, K2G6E2, Canada
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Toronto, Ontario, M5B1W8, Canada
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Gatineau, Quebec, J8Y1W7, Canada
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Greenfield Park, Quebec, J4V2H1, Canada
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Montreal, Quebec, H3A2B4, Canada
Related Publications (1)
O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4.
PMID: 24898925BACKGROUND
Related Links
- The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.)
- (MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Idec Study Medical Director
- Organization
- Biogen Idec
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2006
First Posted
March 24, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2007
Study Completion
February 1, 2008
Last Updated
March 21, 2017
Results First Posted
January 26, 2010
Record last verified: 2017-02