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 While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML).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 (Tysabri) Re-Initiation of Dosing
- First Posted Date
- 2006-02-28
- Last Posted Date
- 2016-07-15
- Lead Sponsor
- Biogen
- Target Recruit Count
- 1094
- Registration Number
- NCT00297232
- Locations
- 🇬🇧
Research Site, Stoke on Trent, United Kingdom
Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease
- Conditions
- First Posted Date
- 2006-01-24
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 2000
- Registration Number
- NCT00280956
- Locations
- 🇺🇸
Performed only at CD251, CD301, CD303, CD306, and CD307 sites globally. No general public enrollment. The study is managed from the office of Elan Pharmaceuticals, Inc. in, San Diego, California, United States
Open-Label Natalizumab Safety Extension Study
- First Posted Date
- 2006-01-13
- Last Posted Date
- 2009-06-22
- Lead Sponsor
- Biogen
- Target Recruit Count
- 1615
- Registration Number
- NCT00276172
- Locations
- 🇺🇸
Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in, Cambridge, Massachusetts, United States
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
- Conditions
- Interventions
- First Posted Date
- 2004-12-01
- Last Posted Date
- 2009-06-18
- Lead Sponsor
- Biogen
- Target Recruit Count
- 110
- Registration Number
- NCT00097760
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
- First Posted Date
- 2004-06-03
- Last Posted Date
- 2016-07-18
- Lead Sponsor
- Biogen
- Target Recruit Count
- 299
- Registration Number
- NCT00083759
- Locations
- 🇺🇸
Clinical Pharmacology Study Group, Worcester, Massachusetts, United States
🇺🇸Justus Fiechtner, MD, PC, Lansing, Michigan, United States
🇨🇦The Arthritis Program Research Group Inc., Newmarket, Ontario, Canada
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
- Conditions
- First Posted Date
- 2004-03-08
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 462
- Registration Number
- NCT00078611
- Locations
- 🇺🇸
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo, Washington, District of Columbia, United States
🇨🇦University of Calgary, Calgary, Alberta, Canada
🇨🇦University of Alberta, Edmonton, Alberta, Canada
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
- Conditions
- First Posted Date
- 2003-03-06
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 60
- Registration Number
- NCT00055536
- Locations
- 🇺🇸
Wake Research Associates, Raleigh, North Carolina, United States
🇺🇸University of Kentucky Medical Center, Lexington, Kentucky, United States
🇺🇸Memphis Gastroenterology Group, Memphis, Tennessee, United States
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
- Conditions
- First Posted Date
- 2003-02-28
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 30
- Registration Number
- NCT00055367
- Locations
- 🇺🇸
The Children's Hospital, Boston, Massachusetts, United States
🇺🇸Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
🇺🇸Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
- Conditions
- First Posted Date
- 2002-04-04
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Registration Number
- NCT00032786
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
- Conditions
- First Posted Date
- 2002-04-04
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 905
- Registration Number
- NCT00032799
- Locations
- 🇺🇸
Elan Pharmaceuticals, San Diego, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.