Actively Recruiting
Kesimpta (Ofatumumab) Pregnancy Registry Observing Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Using OTIS and DMSKW Registries
Led by Novartis Pharmaceuticals · Updated on 2025-01-14
725
Participants Needed
1
Research Sites
529 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pregnancy and infant outcomes in women treated with Kesimpta (ofatumumab) during pregnancy for multiple sclerosis (MS). This observational pregnancy registry study aims to collect data over approximately 7 years, following pregnant women and their infants for up to 21 months. The study combines information from two independent pregnancy registries: the OTIS Research Group in the USA and the German MS and pregnancy registry (DMSKW). The study includes two sub-studies enrolling pregnant women with MS or without MS, depending on the registry. Participants receive no assigned treatment as this is a non-interventional study. Women exposed to Kesimpta from 166 days before the last menstrual period through the end of pregnancy are included in the Kesimpta-exposed cohort. Comparison groups include women with MS who may have taken other MS medications during pregnancy and healthy pregnant women without MS (specific to the OTIS sub-study). Participants will provide data through interviews, medical record releases, infant examinations (including dysmorphology exams in the OTIS group), and developmental questionnaires for live-born children. Researchers will monitor pregnancy outcomes, including the number of participants with major structural birth defects up to 21 months after birth. The study gathers comprehensive safety information on Kesimpta exposure during pregnancy through ongoing follow-up and data analysis.
CONDITIONS
Official Title
Kesimpta (Ofatumumab) Pregnancy Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women
- Diagnosed with multiple sclerosis, confirmed by medical records when possible (for Kesimpta-Exposed and Disease-Matched Comparison Cohorts)
- Administered Kesimpta for MS treatment from 166 days before last menstrual period through pregnancy end (Kesimpta-Exposed Cohort)
- May or may not have taken other MS medication during current pregnancy (Disease-Matched Comparison Cohort)
- Agree to study requirements including interviews, medical record release, infant dysmorphology examinations (OTIS specific), and developmental questionnaires
- Pregnant women without MS agreeing to study conditions (Healthy Comparison Cohort, OTIS sub-study only)
You will not qualify if you...
- Previous enrollment in the Kesimpta cohort study with a prior pregnancy (Kesimpta-Exposed Cohort)
- Use of Kesimpta for non-approved indications
- Exposure to anti-CD20 monoclonal antibodies, S1P modulators, Cladribine, Teriflunomide, or new MS medications within 5 half-lives before conception (Kesimpta-Exposed and Disease-Matched Comparison Cohorts)
- Retrospective enrollment after pregnancy outcome is known
- Positive diagnostic tests indicating major structural defects before enrollment
- For Disease-Matched Comparison Cohort: prior Kesimpta or Mayzent cohort enrollment
- For Healthy Comparison Cohort (OTIS only): use of Kesimpta or Mayzent around conception or during pregnancy, diagnosis of MS or autoimmune disease, prenatal diagnosis of major structural defects, treatment with Kesimpta or Mayzent for non-MS indications, exposure to known teratogenic drugs during pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego OTIS
La Jolla, California, United States, 92093-0934
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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