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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.