Comparing early and late use of Ofatumumab in patients with relapsing multiple sclerosis in Austria

Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years- A Non-interventional Observational Study

This study is testing whether starting treatment with Ofatumumab early or late helps people with relapsing multiple sclerosis feel better over two years.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: Ofatumumab, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab
• Locations: 2 sites (Mistelbach and 1 other locations)
• Trial ID: NCT05776888 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of early versus late treatment with Ofatumumab in patients with relapsing multiple sclerosis (RMS) over a period of 24 months. It will involve two cohorts: one consisting of treatment-naive patients or those who started Ofatumumab within three years of their first therapy, and another comprising patients who have been on other disease-modifying therapies for at least three years before switching to Ofatumumab. The study will take place in a real-world medical setting across multiple centers in Austria, focusing on the clinical outcomes and disease activity of participants.

Who should consider this trial

Good fit: Ideal candidates include patients with relapsing multiple sclerosis who are either treatment naive or have been on other therapies for at least three years before starting Ofatumumab.

Not a fit: Patients who have not been diagnosed with relapsing multiple sclerosis or those who have not received Ofatumumab treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the optimal timing of Ofatumumab treatment, potentially improving patient outcomes in RMS.

How similar studies have performed: Other studies have explored the effects of different treatment timings in multiple sclerosis, but this specific comparison of early versus late Ofatumumab use is novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis.
2. Written informed consent must be obtained before participating in the study.
3. Patient is willing and able to complete the assessments, as outlined in this study.
4. Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
5. Patients in both cohorts must have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
6. Cohort 1: Patients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation.
7. Cohort 2: Patients must have been on either BRACE or Teriflunomide or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated. Thus, this cohort includes patients that use Ofatumumab as second or later line DMT.

Exclusion Criteria:

1. Patients who have been on Ofatumumab less than 3 months or more than 12 months before inclusion.
2. Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
3. Use of any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod, Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron or Cladribine) in either cohort prior to the initiation of Ofatumumab.
4. Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to the initiation of Ofatumumab.

Where this trial is running

Mistelbach and 1 other locations

• Novartis Investigative Site — Mistelbach, Austria (Recruiting)
• Novartis Investigative Site — Vienna, Austria (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Relapsing Multiple Sclerosis; relapsing multiple sclerosis; RMS; Ofatumumab; NIS