Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: Ofatumumab for Relapsing Multiple Sclerosis

This non-treatment 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.

Official registry: https://clinicaltrials.gov/study/NCT05809986 · Novartis Pharmaceuticals · enrollment listed as 174

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 174 people at 8 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

Interventions: Ofatumumab

Primary outcome (registry wording): Proportion of patients demonstrating NEDA-3

Who it is for (from inclusion criteria)

  • Ages 18 Years to 99 Years
  • To participate in the study, all the following who can join must be met:
  • Patients aged 18 years or older
  • 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

Public study contact (from the registry)

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

8 listed

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FAQ about this NCT record

Is NCT05809986 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05809986?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05809986?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary