Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study

Launched by NOVARTIS PHARMACEUTICALS · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called ofatumumab (brand name Kesimpta) on patients with relapsing multiple sclerosis (RMS) in Greece. The goal is to see how well this treatment works in everyday medical care compared to standard treatments like glatiramer acetate or interferons. The study is currently recruiting participants who are between 18 and 75 years old and have been diagnosed with RMS within the last three years. To be eligible, patients should have been receiving ofatumumab for at least three months and must have had a brain MRI scan after starting the treatment.

Participants in this study can expect to undergo regular assessments, including questionnaires about their health, as part of their routine care. It's important to note that women who are pregnant, planning to become pregnant, or breastfeeding cannot participate in this study. Overall, this trial aims to gather valuable information about how well ofatumumab works for people living with RMS in a real-world setting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written IC must be obtained before participating in the study.
• • 2. Patients with diagnosis of RMS per McDonald Criteria (2017) and \<5 years since first MS symptom prior to initiation of ofatumumab.
• • 3. Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study.
• • 4. Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features).
• • 5. Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study.
• • Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In case it is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatment should be brain gadolinium enhanced, for relevant comparison and identification of new lesions. This MRI scan will serve as the index reference assessment for the evaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.
• • 6. Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.
• 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. Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.