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 While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML).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
-

Natalizumab De-escalation With Interferon Beta-1b

First Posted Date
2010-06-15
Last Posted Date
2014-04-17
Lead Sponsor
Claudio Gobbi
Target Recruit Count
19
Registration Number
NCT01144052
Locations
🇨🇭

Neurocenter of Southern Switzerland, Ospedale Civico Lugano, Lugano, Ticino, Switzerland

Natalizumab Treatment of Progressive Multiple Sclerosis

First Posted Date
2010-03-01
Last Posted Date
2012-02-17
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
24
Registration Number
NCT01077466
Locations
🇩🇰

Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet, Copenhagen, Denmark

Treatment Interruption of Natalizumab

First Posted Date
2010-02-19
Last Posted Date
2013-09-19
Lead Sponsor
Biogen
Target Recruit Count
175
Registration Number
NCT01071083
Locations
🇪🇸

Research Site, Valencia, Spain

JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

Completed
Conditions
Interventions
First Posted Date
2010-02-18
Last Posted Date
2016-09-29
Lead Sponsor
Biogen
Target Recruit Count
35895
Registration Number
NCT01070836
Locations
🇵🇷

Research Site, Ponce, Puerto Rico

Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment

Phase 4
Completed
Conditions
First Posted Date
2009-07-20
Last Posted Date
2011-03-30
Lead Sponsor
University Hospital, Toulouse
Target Recruit Count
300
Registration Number
NCT00942214
Locations
🇫🇷

service de neurologie, hôpital Purpan, Toulouse, France

Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy

Phase 4
Withdrawn
Conditions
First Posted Date
2008-12-03
Last Posted Date
2016-06-16
Lead Sponsor
Biogen
Registration Number
NCT00801125

A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-09-01
Last Posted Date
2015-02-10
Lead Sponsor
Biogen
Target Recruit Count
20
Registration Number
NCT00744679
Locations
🇺🇸

Research Site, Latham, New York, United States

CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Terminated
Conditions
First Posted Date
2008-07-01
Last Posted Date
2024-06-03
Lead Sponsor
Biogen
Target Recruit Count
87
Registration Number
NCT00707512
Locations
🇵🇷

Research site, San Juan, Puerto Rico

Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

First Posted Date
2007-11-16
Last Posted Date
2014-09-09
Lead Sponsor
Biogen
Target Recruit Count
76
Registration Number
NCT00559702
Locations
🇺🇸

Research Site, Vienna, Virginia, United States

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