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
Novartis Pharmaceuticals
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.
Description
The study is expected to enroll for approximately 7 years and follow the pregnant women and their infant(s) over a maximum of 21 months. The study will be conducted as two sub-studies leveraging independent ongoing pregnancy registries: * The Organization of Teratology Information Specialists (OTIS) Research Group, University of California, San Diego, USA (referred to as "OTIS") will serve as data source for the Kesimpta-OTIS sub-study; * The German MS and pregnancy registry - Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW) at Katholisches Klinikum Bochum gGmbH, St Jose…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- OtherKesimpta
Prospective non-interventional study. There is no treatment allocation. Patients participating in from the two independent sub-studies, namely the Kesimpta-OTIS sub-study and Kesimpta-DMSKW sub-study, of identical design, conducted in parallel, enrolling pregnant women (MS and non-MS) residing in US or Canada and pregnant women (MS only) from Germany respectively are eligible for enrolling to this study.
Location
- University of California San Diego OTISLa Jolla, California