Last Update: May 16, 2024
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157GPT04
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This non-interventional study will compare the effect of Ofatumumab treatment between
patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and
patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in
a real-world setting in Portugal. This is a 2 cohort, multi-center, observational study carried out in Portugal that aims
to describe the effectiveness of Ofatumumab in a setting of routine medical care. Primary
data will be collected from Multiple Sclerosis patients who initiate Ofatumumab early and
later in their disease (cohorts 1 and 2, respectively).

Data will be collected during 3 visits distributed over a maximum period of 24 months.
Exceptionally, if the patient shows Expanded Disability Status Scale (EDSS) worsening in
visit 2 or 3 (12 and 24 months after Ofatumumab initiation, respectively), there will be
an additional visit 6±1 months after visit 2 or 3 for EDSS confirmation.

The study includes patients that have initiated Ofatumumab up to 12 months prior
inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study
inclusion.

Patients in both cohorts will have to be treated with Ofatumumab for at least two years
to compare No Evidence of Disease Activity (NEDA)-3 at 12 to 24 months, respectively.

Relapsing Multiple Sclerosis
Recruiting
174
Nov 27, 2023
Sep 15, 2026
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

Ofatumumab

There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis

Eligibility Criteria

Inclusion Criteria:

To participate in the study, all the following inclusion criteria must be met:

- Patients aged 18 years or older

- Written informed consent obtained before participating in the study.

- Patient is willing and able to complete the assessments, including PRO
questionnaires, as outlined in this study.

- Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of
Ofatumumab.

- Treatment with Ofatumumab is in accordance with the Portuguese indication of
Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS)
with active disease defined by clinical or imaging features).

- Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR
Patients that are initiating Ofatumumab at the moment of study inclusion.

Exclusion Criteria:

To participate in the study, none of the following exclusion criteria must be met:

- 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.

- Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone,
Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.

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