Status:
RECRUITING
Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis (RMS)
Eligibility:
All Genders
18-55 years
Brief Summary
This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Scle...
Detailed Description
Primary data from MS adult patients who initiate ofatumumab early in their disease course will be collected over a period of two years, and will be compared to the ofatumumab and Standard of Care (SoC...
Eligibility Criteria
Inclusion
- Written IC must be obtained before participating in the study.
- Patients with diagnosis of RMS per McDonald Criteria (2017) and \<5 years since first MS symptom prior to initiation of ofatumumab.
- 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.
- 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).
- 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.
- Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.
Exclusion
- 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.
- Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.
Key Trial Info
Start Date :
December 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06486779
Start Date
December 10 2024
End Date
December 30 2028
Last Update
December 24 2025
Active Locations (14)
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1
Novartis Investigative Site
Alexandroupoli, Greece, 681 00
2
Novartis Investigative Site
Athens, Greece, 115 21
3
Novartis Investigative Site
Athens, Greece, 115 25
4
Novartis Investigative Site
Athens, Greece, 115 27