Actively Recruiting
Kesimpta (Ofatumumab) Pregnancy Registry
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
The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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