NCT05809986 Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
| NCT ID | NCT05809986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Relapsing Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 174 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 174 participants in total. It began in 2023-11-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05809986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Relapsing Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05809986 currently recruiting?
Yes, NCT05809986 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05809986 trial being conducted?
This trial is being conducted at Amadora, Portugal, Guimarães, Portugal, Leiria, Portugal, Lisbon, Portugal and 6 additional locations.
Who is sponsoring the NCT05809986 clinical trial?
NCT05809986 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 174 participants.
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