Multiple Sclerosis, Pregnancy
Conditions
Keywords
PASS, Kesimpta, ofatumumab, Pregnancy, Multiple Sclerosis
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.
Detailed 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 Josef Hospital, Bochum, Germany (referred to as DMSKW) will serve as data source for the Kesimpta- DMSKW sub-study. Both registries will independently collect and assess data related to the pregnancy and infant outcomes of interest and provide aggregate data which will be further combined (metaanalyses) by Novartis (referred to as the Sponsor) or a designated contract research organization (CRO).
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.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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 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 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 1. Pregnant women 2. 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
Exclusion criteria
Women meeting any of the following criteria will be excluded from the cohort study: Cohort 1: Kesimpta-Exposed Cohort 1. Women who have enrolled in the Kesimpta cohort study with a previous pregnancy 2. Women who have used Kesimpta for an indication other than a currently approved indication 3. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception: * Other anti-CD20 monoclonal antibody: same class as Kesimpta * S1P modulators: same class as Mayzent * Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine * Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation. * New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with major structural defects | Up to 21 months | Number of participants with major structural defects will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of stillbirth cases | Up to 21 months | Number of stillbirth cases will be collected |
| Number of elective termination cases | Up to 21 months | Number of elective termination cases will be collected |
| Number of preterm delivery cases | Up to 21 months | Number of preterm delivery cases will be collected |
| Number of preeclampsia / eclampsia cases | Up to 21 months | Number of preeclampsia / eclampsia cases will be collected |
| Number of cases with pattern of 3 or more minor structural defects | Up to 21 months | Number of cases with pattern of 3 or more minor structural defects will be collected |
| Number of participants with spontaneous abortion/miscarriage | Up to 21 months | Number of participants with spontaneous abortion/miscarriage will be collected |
| Number of participants with postnatal growth small for age at one year of age | Up to 21 months | Number of participants with postnatal growth small for age at one year of age will be collected |
| Developmental performance at approximately one year of age: Michaelis developmental milestones questionnaires | Up to 21 months | The Michaelis developmental milestones questionnaires will be used to assess the developmental performance in live born infants. |
| Developmental performance at approximately one year of age: Denver developmental screening test | Up to 21 months | Denver developmental screening test will be used to assess the developmental performance in live born infants; |
| Number of serious or opportunistic infections in the first year of life. | Up to 21 months | Number of serious or opportunistic infections in the first year of life will be collected |
| Number of participants small for gestational age | Up to 21 months | Number of participants small for gestational age will be collected |
Countries
United States
Contacts
Primary ContactNovartis Pharmaceuticals
Backup ContactNovartis Pharmaceuticals
Outcome results
None listed