Plain-English translation of NCT05634967 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Multiple Sclerosis research guide →This is a safety study following pregnant women with multiple sclerosis and their babies over about 21 months. Some women in the study took Kesimpta (ofatumumab), a medication used to treat multiple sclerosis, while others did not. The study compares pregnancy and infant health outcomes between these groups to make sure the medication is safe to use during pregnancy.
Even though this medication has been approved for multiple sclerosis, doctors and patients need real-world safety information about what happens when pregnant women take it. This study provides that important information by following actual pregnancies and tracking how babies develop.
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You would be enrolled while pregnant and followed for up to 21 months after your baby is born. Participation involves sharing your medical records, participating in interviews about your pregnancy and health, and allowing your infant to have physical examinations and developmental assessments. The study runs through two independent pregnancy registries—one in the United States and one in Germany—and will compare outcomes between women who took the medication and those who did not.
AI-generated summary from trial data · Jun 4, 2026 · Not medical advice
United States
Sponsor
Novartis Pharmaceuticals
Enrollment target
~725 participants
Started
January 2023
Primary completion
February 2033
Age range
18 Years – 100 Years
Last updated on clinicaltrials.gov in January 2025.
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Central contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
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