Observing the effects of Ofatumumab in Swiss patients with Multiple Sclerosis

Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)

This study is testing how well Ofatumumab works for Swiss patients with relapsing Multiple Sclerosis compared to standard treatments over a year.

Quick facts

• Study type: Observational
• Enrollment: 149 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: Ofatumumab
• Locations: 18 sites (Baden, Aargau and 17 other locations)
• Trial ID: NCT05285904 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of Ofatumumab treatment in patients with relapsing forms of Multiple Sclerosis in Switzerland. Conducted in a real-world setting, it will compare the outcomes of patients receiving Ofatumumab to those in a standard of care group from a closely monitored phase-IIIb study. The study will follow participants for a period of 12 months, collecting data on their health and treatment responses. Patients will be required to maintain a diary and complete patient-reported outcome questionnaires throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adult patients diagnosed with relapsing forms of Multiple Sclerosis who have been treated with Ofatumumab for at least 3 months but not more than 12 months.

Not a fit: Patients who have used investigational drugs recently or are unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of Ofatumumab for treating Multiple Sclerosis.

How similar studies have performed: Other studies have shown success with similar observational approaches in evaluating treatment effects in Multiple Sclerosis, making this study a continuation of established methodologies.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent must be obtained before participating in the study.
2. Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to initiation of Ofatumumab.
3. Adult patients who have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
4. Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients with active, relapsing forms of MS)
5. Patient is willing and able to complete patient diary during course of the study, as well as to complete PRO questionnaires.

Exclusion Criteria:

1. Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 3 months before Ofatumumab initiation, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
2. Subjects who are not able to provide consent due to incapable judgement

Where this trial is running

Baden, Aargau and 17 other locations

• Novartis Investigative Site — Baden, Aargau, Switzerland (Recruiting)
• Novartis Investigative Site — Liestal, Bl, Switzerland (Withdrawn)
• Novartis Investigative Site — Zuerich, Che, Switzerland (Recruiting)
• Novartis Investigative Site — Chur, Gr, Switzerland (Withdrawn)
• Novartis Investigative Site — Luzern, Lu, Switzerland (Recruiting)
• Novartis Investigative Site — Sargans, Saint Gallen, Switzerland (Recruiting)
• Novartis Investigative Site — Wil, Sg, Switzerland (Withdrawn)
• Novartis Investigative Site — Gland, Vaud, Switzerland (Recruiting)
• Novartis Investigative Site — Zug, Zg, Switzerland (Recruiting)
• Novartis Investigative Site — Zurich, Zh, Switzerland (Recruiting)
• Novartis Investigative Site — Basel, Switzerland (Recruiting)
• Novartis Investigative Site — Bern, Switzerland (Recruiting)
• Novartis Investigative Site — Lausanne, Switzerland (Recruiting)
• Novartis Investigative Site — Lugano, Switzerland (Recruiting)
• Novartis Investigative Site — Luzern, Switzerland (Recruiting)
• Novartis Investigative Site — Luzern, Switzerland (Recruiting)
• Novartis Investigative Site — Sion, Switzerland (Recruiting)
• Novartis Investigative Site — Zuerich, Switzerland (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Multiple Sclerosis; NIS; Multiple sclerosis; MS; KOSMOS; Ofatumumab; Kesimpta