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
-

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

First Posted Date
2021-05-07
Last Posted Date
2024-06-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT04878211
Locations
🇺🇸

Dragonfly Research LLC, Wellesley, Massachusetts, United States

🇺🇸

Minnesota Center Multiple Sclerosis, Plymouth, Minnesota, United States

🇺🇸

The MS Center for Innovation in Care, Saint Louis, Missouri, United States

and more 4 locations

Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab

Phase 4
Completed
Conditions
Interventions
First Posted Date
2021-05-03
Last Posted Date
2024-12-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
34
Registration Number
NCT04869358
Locations
🇩🇪

Novartis Investigative Site, Unterhaching, Germany

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-03-09
Last Posted Date
2024-10-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
185
Registration Number
NCT04788615
Locations
🇪🇸

Novartis Investigative Site, Valencia, Spain

Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

First Posted Date
2020-12-21
Last Posted Date
2022-10-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
2
Registration Number
NCT04676555
Locations
🇦🇺

Novartis Investigative Site, Parkville, Victoria, Australia

A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

First Posted Date
2020-12-14
Last Posted Date
2024-10-09
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
63
Registration Number
NCT04667117
Locations
🇺🇸

The MS Center for Innovation in Care, Saint Louis, Missouri, United States

🇺🇸

Hope Research Institute Center Neurology and Spine, Phoenix, Arizona, United States

🇺🇸

Infinity Clinical Research LLC, Hollywood, Florida, United States

9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

First Posted Date
2020-08-12
Last Posted Date
2021-07-27
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
10
Registration Number
NCT04510220
Locations
🇺🇸

Partners MS Center, 60 Fenwood Road, Boston, Massachusetts, United States

A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-07-27
Last Posted Date
2024-12-05
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
111
Registration Number
NCT04486716
Locations
🇺🇸

Alabama Neurology Associates PC, Birmingham, Alabama, United States

🇺🇸

AMO Corporation, Tallahassee, Florida, United States

🇺🇸

University Of South Florida, Tampa, Florida, United States

and more 17 locations

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-04-20
Last Posted Date
2024-10-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
564
Registration Number
NCT04353492
Locations
🇺🇸

Fullerton Neuro and Headache Ctr, Fullerton, California, United States

🇺🇸

CU Anschutz Med Campus, Aurora, Colorado, United States

🇺🇸

Christiana Care Health Services, Newark, Delaware, United States

and more 19 locations

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

First Posted Date
2018-08-28
Last Posted Date
2024-11-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
2060
Registration Number
NCT03650114
Locations
🇺🇸

Mountain Neuro Research Center PC, Basalt, Colorado, United States

🇺🇸

Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States

🇺🇸

Colorado Neurological Research PC, Denver, Colorado, United States

and more 86 locations

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

First Posted Date
2017-08-15
Last Posted Date
2022-04-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
64
Registration Number
NCT03249714
Locations
🇷🇺

Novartis Investigative Site, Novosibirsk, Russian Federation

© Copyright 2024. All Rights Reserved by MedPath