Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Portugal
Novartis Investigative Site
RECRUITING
Amadora
Novartis Investigative Site
RECRUITING
Guimarães
Novartis Investigative Site
RECRUITING
Leiria
Novartis Investigative Site
RECRUITING
Lisbon
Novartis Investigative Site
RECRUITING
Lisbon
Novartis Investigative Site
RECRUITING
Lisbon
Novartis Investigative Site
RECRUITING
Matosinhos Municipality
Novartis Investigative Site
RECRUITING
Ponte De Lima
Novartis Investigative Site
RECRUITING
Porto
Novartis Investigative Site
RECRUITING
Setúbal
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 174
Treatments
Cohort 1: Early treatment arm
All patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch).
Cohort 2: Late treatment arm
All patients who initiated Ofatumumab with more than 3 years of MS diagnosis.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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