Observing the effects of Ofatumumab in Portuguese patients with relapsing multiple sclerosis

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

This study is testing how well Ofatumumab works for Portuguese patients with relapsing multiple sclerosis who started treatment either within three years of their diagnosis or after, to see if it helps them stay symptom-free.

Quick facts

• Study type: Observational
• Enrollment: 174 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: Ofatumumab, Ocrelizumab, Natalizumab, Rituximab, Alemtuzumab
• Locations: 10 sites (Amadora and 9 other locations)
• Trial ID: NCT05809986 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the effectiveness of Ofatumumab treatment in two groups of patients with relapsing multiple sclerosis (RMS) in Portugal. One group consists of patients who started Ofatumumab within three years of their diagnosis, while the other group includes those who began treatment after three years. Data will be collected over a maximum of 24 months through three visits, with additional assessments if patients show worsening symptoms. The study seeks to evaluate the rate of No Evidence of Disease Activity (NEDA)-3 between the two cohorts.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older with a diagnosis of relapsing multiple sclerosis who are either initiating Ofatumumab treatment or have started it within the last 12 months.

Not a fit: Patients who have not been diagnosed with relapsing multiple sclerosis or those currently using investigational drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the optimal timing for initiating Ofatumumab treatment in RMS patients, potentially improving patient outcomes.

How similar studies have performed: While this approach is observational and may not have been extensively tested in this specific context, similar studies have shown promise in evaluating treatment effectiveness in real-world settings.

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.

Where this trial is running

Amadora and 9 other locations

• Novartis Investigative Site — Amadora, Portugal (Recruiting)
• Novartis Investigative Site — Guimarães, Portugal (Recruiting)
• Novartis Investigative Site — Leiria, Portugal (Recruiting)
• Novartis Investigative Site — Lisbon, Portugal (Recruiting)
• Novartis Investigative Site — Lisbon, Portugal (Recruiting)
• Novartis Investigative Site — Lisbon, Portugal (Recruiting)
• Novartis Investigative Site — Matosinhos Municipality, Portugal (Recruiting)
• Novartis Investigative Site — Ponte de Lima, Portugal (Recruiting)
• Novartis Investigative Site — Porto, Portugal (Recruiting)
• Novartis Investigative Site — Setúbal, Portugal (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Relapsing Multiple Sclerosis; RMS; Ofatumumab; NIS; Portugal