Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years

Launched by NOVARTIS PHARMACEUTICALS · Mar 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how early or late treatment with Ofatumumab (also known as Kesimpta®) affects patients with relapsing multiple sclerosis (RMS) over two years. Researchers want to see if starting this medication sooner, compared to starting it later, makes a difference in managing the disease. The trial is taking place in Austria and is currently looking for participants.

To be eligible for the study, patients must have a diagnosis of RMS and show signs of disease activity, either through clinical assessments or MRI scans. They also need to have started treatment with Ofatumumab within a specific timeframe, depending on whether they have previously received other treatments for RMS. Participants will need to provide consent and be willing to complete assessments throughout the study. This is an important opportunity for patients to contribute to understanding how timing in treatment can influence outcomes in RMS.

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ALL

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.