Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry
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.
⁃ 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
• Pregnant women
• Diagnosed with MS, with the indication validated by medical records when possible
• 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
• 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)
• Pregnant women
• Diagnosed with MS, with the indication validated by medical records when possible
• May or may not have taken another medication for MS in the current pregnancy
• 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 3: Healthy Comparison Cohort (Comparison Group 2):Kesimpta-OTIS sub-study specific
• Pregnant women
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children