NCT05634967 Kesimpta (Ofatumumab) Pregnancy Registry
| NCT ID | NCT05634967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 725 participants |
| Start Date | 2023-01-05 |
| Primary Completion | 2033-02-28 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry: Cohort 1: Kesimpta-Exposed Cohort 1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy 4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1) 1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. May or may not have taken another medication for MS in the current pregnancy 4. Agree to the conditions and requirements of th
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