Natalizumab

Generic Name
Natalizumab
Brand Names
Tysabri, Tyruko
Drug Type
Biotech
Chemical Formula
-
CAS Number
189261-10-7
Unique Ingredient Identifier
3JB47N2Q2P
Background

Natalizumab is a recombinant humanized IgG4κ monoclonal antibody that binds to α4-integrin. While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the market for mu...

Indication

Natalizumab is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
...

Associated Conditions
Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), Severe Crohn's Disease, Moderate Crohn’s Disease
Associated Therapies
-

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

First Posted Date
2015-01-21
Last Posted Date
2017-06-09
Lead Sponsor
Biogen
Target Recruit Count
111
Registration Number
NCT02342704
Locations
🇬🇧

Research Site, Glasgow, Strathclyde, United Kingdom

Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya

First Posted Date
2014-12-25
Last Posted Date
2014-12-25
Lead Sponsor
University Hospital Muenster
Target Recruit Count
15
Registration Number
NCT02325440
Locations
🇩🇪

Universitaetsklinikum Muenster, Department of Neurology, Muenster, Germany

Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2014-09-16
Last Posted Date
2017-06-05
Lead Sponsor
Biogen
Target Recruit Count
47
Registration Number
NCT02241785
Locations
🇺🇸

Research Site, Tacoma, Washington, United States

Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD

First Posted Date
2014-06-26
Last Posted Date
2020-04-17
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
21
Registration Number
NCT02176031
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Natalizumab Subcutaneous Immunogenicity and Safety Study

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2014-05-20
Last Posted Date
2024-06-03
Lead Sponsor
Biogen
Target Recruit Count
2
Registration Number
NCT02142192
Locations
🇧🇪

Research Site, Liege, Belgium

Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Completed
Conditions
Interventions
First Posted Date
2014-05-13
Last Posted Date
2015-10-20
Lead Sponsor
Biogen
Target Recruit Count
400
Registration Number
NCT02137109

Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease

First Posted Date
2014-05-08
Last Posted Date
2022-10-21
Lead Sponsor
John Levine
Target Recruit Count
76
Registration Number
NCT02133924
Locations
🇺🇸

Northwestern, Chicago, Illinois, United States

🇺🇸

Ohio State University, Columbus, Ohio, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 9 locations

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-10-07
Last Posted Date
2016-07-01
Lead Sponsor
Biogen
Target Recruit Count
161
Registration Number
NCT01955707
Locations
🇪🇸

Research Site, Valladolid, Spain

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis

First Posted Date
2011-08-12
Last Posted Date
2017-09-11
Lead Sponsor
Biogen
Target Recruit Count
889
Registration Number
NCT01416181
Locations
🇬🇧

Research Site, Sheffield, United Kingdom

Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis

First Posted Date
2011-08-12
Last Posted Date
2016-01-14
Lead Sponsor
Biogen
Target Recruit Count
97
Registration Number
NCT01416155
Locations
🇯🇵

Research Site, Osaka, Japan

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