Kesimpta (Ofatumumab) Pregnancy Registry for Multiple Sclerosis

This study, called the Kesimpta Pregnancy Registry, is looking at the effects of Kesimpta (ofatumumab) when taken by pregnant women with Multiple Sclerosis (MS). It's an observational study, meaning researchers will collect information from women who are already taking Kesimpta during pregnancy, rather than assigning them to a treatment. The main goal is to see how many babies born to these mothers have major birth defects. You can join if you are a pregnant woman, aged 18 to 100, diagnosed with MS, and are taking Kesimpta. This study aims to enroll 725 participants.

Study design
This is an observational study, not assigning any treatment. It will involve 725 participants and is conducted through two existing pregnancy registries.
What's involved
Pregnant women and their infants will be followed for a maximum of 21 months. The study will collect and assess data related to pregnancy and infant outcomes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 21 months after pregnancy.

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NCT05634967

Kesimpta (Ofatumumab) Pregnancy Registry

Recruiting
Not specifiedAges 18+Observational
Novartis Pharmaceuticals
~725 participants
Updated 2025-01-14 on ClinicalTrials.gov
What's tested:Kesimpta

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with major structural defects
Measured over Up to 21 months
Multiple Sclerosis
Pregnancy
1 sites across 1 states
California1
  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

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Eligibility criteria

Inclusion

Anti CD-20 monoclonal antibody
Cladribine (Mavenclad)
S1P modulators

Exclusion

Other anti-CD20 monoclonal antibody: same class as Kesimpta
S1P modulators: same class as Mayzent
Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine
Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation.
  • Number of participants with major structural defectsUp to 21 months

    Number of participants with major structural defects will be collected