What the trial was testing
The ASCLEPIOS I enrolled 946 patients with multiple sclerosis. The study was sponsored by Novartis and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
About half as many MS relapses per year compared with teriflunomide.
New England Journal of Medicine · 2020 · NCT02792218
These findings — that per year on ofatumumab compared with teriflunomide in relapsing MS — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 946 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with multiple sclerosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Ofatumumab (Kesimpta) is FDA-approved for relapsing forms of multiple sclerosis and available now. It is given as a once-monthly injection at home — no infusion center needed. Most common side effects are injection-site reactions and upper respiratory infections. Ask your neurologist whether it fits your case.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open multiple sclerosis trials
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
Postoperative Relapses in MS Patients
The aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia