Registry to track pregnancy outcomes in women using Kesimpta for MS
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 · NCT05634967
This study is looking at how using Kesimpta during pregnancy affects women with multiple sclerosis and their babies to help understand its safety and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 725 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis (industry) |
| Drugs / interventions | ofatumumab |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05634967 on ClinicalTrials.gov |
What this trial studies
The Kesimpta Pregnancy Registry is an observational study designed to examine the outcomes of pregnancies and infants exposed to Kesimpta (ofatumumab) during pregnancy in women diagnosed with multiple sclerosis (MS). The study will enroll participants over approximately 7 years and follow them for up to 21 months post-delivery. It consists of two sub-studies utilizing existing pregnancy registries, one in the USA and one in Germany, to collect and analyze data on pregnancy and infant outcomes. The data will be aggregated and analyzed to provide insights into the safety and effects of Kesimpta during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include pregnant women diagnosed with multiple sclerosis who have been treated with Kesimpta or are part of a disease-matched comparison group.
Not a fit: Patients who are not pregnant or those without a diagnosis of multiple sclerosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and outcomes of using Kesimpta during pregnancy, helping to inform treatment decisions for pregnant women with MS.
How similar studies have performed: While there have been studies on pregnancy outcomes in women with MS, this specific registry approach focusing on Kesimpta is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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/exclusion criteria as the study progresses. 4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1) 1. Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy 2. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception: * Anti CD-20 monoclonal antibody * Cladribine (Mavenclad) * S1P modulators * Teriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses. 3. Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancy 4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. Cohort 3: Healthy Comparison Cohort (Comparison Group 2): Only applicable to Kesimpta-OTIS sub-study 1. Administered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancy 2. Women who have a diagnosis of a MS 3. Women who have a current diagnosis of any autoimmune disease 4. Women who have first contact with the project after prenatal diagnosis of any major structural defect 5. Women treated with Mayzent or Kesimpta for non-MS indication 6. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment) 7. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect. 8. Women exposed to a known human teratogenic drugs during pregnancy
Where this trial is running
La Jolla, California
- University of California San Diego OTIS — La Jolla, California, United States (RECRUITING)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Pregnancy, PASS, Kesimpta, ofatumumab