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NCT05809986Recruiting

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
174 (estimated)
First submitted
30 Mar 2023
Start date
27 Nov 2023
Primary completion date
31 Dec 2026
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT05809986

What you commit to

  • Study type: Observational
  • Planned participants: 174
  • From 27 Nov 2023 to the primary completion date, 31 Dec 2026
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
Coordinator of this site? Confirm its status
AmadoraPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
GuimarãesPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
LeiriaPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
Matosinhos MunicipalityPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
Ponte de LimaPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
SetúbalPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.