Ofatumumab
- Generic Name
- Ofatumumab
- Brand Names
- Arzerra, Kesimpta
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 679818-59-8
- Unique Ingredient Identifier
- M95KG522R0
- Background
Ofatumumab is a novel anti-CD20 monoclonal antibody that targets B-cells. It is an IgG1κ human monoclonal antibody produced from a recombinant murine cell line (NS0) via transgenic mouse and hybridoma technology. Ofatumumab works by recognizing antigens that are expressed on the tumour cells in certain cancers; however, the antigen is not tumour-specific and...
- Indication
Ofatumumab is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
...
- Associated Conditions
- Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia (CLL) - Refractory, Clinically Isolated Syndrome (CIS), Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS), Progressive Chronic Lymphocytic Leukaemia (CLL), Recurrent Chronic Lymphocytic Leukaemia (CLL)
- Associated Therapies
- -
Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
- First Posted Date
- 2010-02-02
- Last Posted Date
- 2023-10-04
- Lead Sponsor
- University of Nebraska
- Target Recruit Count
- 46
- Registration Number
- NCT01060384
- Locations
- 🇺🇸
Saint Francis Medical Center, Grand Island, Nebraska, United States
🇺🇸University of Nebraska Medical Center, Omaha, Nebraska, United States
Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)
- First Posted Date
- 2008-12-05
- Last Posted Date
- 2014-05-14
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 29
- Registration Number
- NCT00802737
- Locations
- 🇸🇪
GSK Investigational Site, Örebro, Sweden
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2008-08-27
- Last Posted Date
- 2017-11-17
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 6
- Registration Number
- NCT00742144
- Locations
- 🇯🇵
GSK Investigational Site, Tokyo, Japan
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients
- First Posted Date
- 2008-05-30
- Last Posted Date
- 2017-06-26
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 35
- Registration Number
- NCT00686868
- Locations
- 🇪🇸
GSK Investigational Site, Madrid, Spain
Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
- First Posted Date
- 2008-04-10
- Last Posted Date
- 2017-12-05
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 124
- Registration Number
- NCT00655824
- Locations
- 🇬🇧
GSK Investigational Site, Ipswich, United Kingdom
Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
- First Posted Date
- 2008-02-25
- Last Posted Date
- 2015-07-24
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 81
- Registration Number
- NCT00622388
- Locations
- 🇬🇧
GSK Investigational Site, London, United Kingdom
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy
- First Posted Date
- 2008-02-11
- Last Posted Date
- 2017-11-06
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 265
- Registration Number
- NCT00611455
- Locations
- 🇬🇧
GSK Investigational Site, Maidstone, United Kingdom
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy
- First Posted Date
- 2008-01-29
- Last Posted Date
- 2014-06-09
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 169
- Registration Number
- NCT00603525
- Locations
- 🇬🇧
GSK Investigational Site, Leytonstone, London, United Kingdom
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
- Conditions
- Interventions
- First Posted Date
- 2007-07-02
- Last Posted Date
- 2014-07-11
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 59
- Registration Number
- NCT00494780
- Locations
- 🇺🇸
GSK Investigational Site, Buffalo, New York, United States
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab
- Conditions
- First Posted Date
- 2006-11-01
- Last Posted Date
- 2014-01-29
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 116
- Registration Number
- NCT00394836
- Locations
- 🇬🇧
GSK Investigational Site, Southampton, United Kingdom
Drug Development Updates
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