Ofatumumab for Multiple Sclerosis
(ARTIOS Trial)
Trial Summary
What is the purpose of this trial?
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.
Eligibility Criteria
This trial is for people with relapsing forms of Multiple Sclerosis (RMS), including secondary progressive MS, who have tried up to three Disease Modifying Therapies. Participants should have an EDSS score from 0 to 4 and must be transitioning from fumarate-based therapies or fingolimod due to disease activity despite treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ofatumumab
Ofatumumab is already approved in European Union, United States for the following indications:
- Relapsing forms of multiple sclerosis (MS)
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
- Relapsing forms of multiple sclerosis (MS)
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
- Certain types of chronic lymphocytic leukemia (CLL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD