Ofatumumab for Multiple Sclerosis
(ARTIOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ofatumumab for individuals with multiple sclerosis (MS) who have not responded well to other medications. It targets those with relapsing forms of MS who have experienced flare-ups or worsening symptoms despite using specific MS drugs like dimethyl fumarate or fingolimod for at least six months. Participants must have a diagnosis of MS with recent breakthrough disease activity and remain stable for at least a month before starting the new treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial requires participants to transition from fumarate-based therapies or fingolimod, which means you will need to stop these medications before starting the study drug. The protocol does not specify a washout period, but you must have been on these medications for at least 6 months before transitioning.
Is there any evidence suggesting that ofatumumab is likely to be safe for humans?
Research shows that ofatumumab, a treatment for relapsing multiple sclerosis (RMS), has been studied for its safety. Real-world data indicate that most patients tolerate it well. Known side effects include injection site reactions and infections, similar to those seen with other treatments in this category.
Studies over several years show that ofatumumab has a good safety record, meaning most people using it do not experience serious side effects. This treatment is already FDA-approved for another condition, suggesting it is safe for human use.
Before joining a clinical trial, discussing any concerns with a healthcare provider is advisable. They can help explain the potential benefits and risks based on personal health needs.12345Why do researchers think this study treatment might be promising for multiple sclerosis?
Ofatumumab is unique because it targets CD20, a specific protein on the surface of B cells, which are part of the immune system involved in multiple sclerosis (MS). Unlike traditional MS treatments, which may involve intravenous infusions or daily oral medications, ofatumumab is administered as a convenient subcutaneous injection once every four weeks. This targeted approach can potentially reduce disease activity with fewer side effects and greater ease of administration, making it an exciting option for both patients and researchers in the fight against MS.
What evidence suggests that ofatumumab might be an effective treatment for multiple sclerosis?
Research has shown that ofatumumab, which participants in this trial will receive, works well for treating relapsing multiple sclerosis (RMS). Studies found that over 80% of patients using ofatumumab did not experience worsening disability for at least six months. In everyday use, patients taking ofatumumab had fewer relapses and less disease activity on MRI scans. Additionally, those who switched from other treatments to ofatumumab saw a significant drop in disease activity. Overall, evidence supports its effectiveness in managing RMS.45678
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Ofatumumab
Trial Overview
The study tests the effectiveness of Ofatumumab in patients switching from fumarate-based RMS therapies or fingolimod because their MS was active even while on these treatments. It's an open-label trial, meaning both researchers and participants know what treatment is being given.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
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
Citations
Five-Year Safety and Efficacy Outcomes with Ofatumumab ...
With ofatumumab treatment up to 5 years, > 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse ...
Real-world effectiveness and safety of ofatumumab in ...
Outcomes included annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS), and the percentage of patients free from relapse, MRI ...
New Novartis data further support benefits of Kesimpta® in ...
ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing ...
Five-Year Safety and Efficacy Outcomes with Ofatumumab ...
With ofatumumab treatment up to 5 years, > 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse ...
5.
practicalneurology.com
practicalneurology.com/news/kesimpta-shows-sustained-long-term-efficacy-and-safety-in-relapsing-multiple-sclerosis/2483559/Kesimpta Shows Sustained Long-Term Efficacy and Safety in ...
Across both studies, Kesimpta demonstrated high rates of no evidence of disease activity (NEDA-3), sustained suppression of MRI activity, and ...
Real-world pharmacovigilance of ofatumumab in multiple ...
This real-world analysis of ofatumumab provides important safety insights, confirming known adverse reactions and identifying additional potential risks.
Real-world pharmacovigilance of ofatumumab in multiple ...
By leveraging real-world data from the FAERS database, this work could identify differences in safety signals that may inform clinical decision- ...
The real-world safety of Ofatumumab - PubMed Central - NIH
This study compiled a dataset derived from the FAERS database, which included real-world safety data on Ofatumumab from Q4 2009 to Q2 2024.
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