Kesimpta (Ofatumumab) Pregnancy Registry

NCT05634967 | Recruiting

• 1 other identifier: COMB157G2403
• Study Type: observational
• Target: 725
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Pregnancy

Keywords

PASS; Kesimpta; ofatumumab; Pregnancy; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with major structural defects

  Number of participants with major structural defects will be collected

  Up to 21 months

Secondary Outcomes (11)

• Number of participants with spontaneous abortion/miscarriage

  Up to 21 months

• Number of stillbirth cases

  Up to 21 months

• Number of elective termination cases

  Up to 21 months

• Number of preterm delivery cases

  Up to 21 months

• Number of preeclampsia / eclampsia cases

  Up to 21 months

Study Arms (3)

Disease-matched cohort (Comparison Group 1)

comparison group consisting of women diagnosed with MS who have not used Kesimpta during pregnancy (unexposed disease-matched comparison group).

Healthy cohort (only applicable in the Kesimpta-OTIS sub-study) (Comparison Group 2)

healthy women who are not diagnosed with MS or any other autoimmune disease, have not had exposure to a known human teratogen, and have not taken Kesimpta in pregnancy (healthy comparison group). Since the DMSKW register is an MS population specific register that does not collect data on non-MS population, this cohort is only applicable in the Kesimpta-OTIS sub-study.

Kesimpta-exposed cohort

women and infants who are exposed to Kesimpta during pregnancy to treat MS.

Other: Kesimpta

Interventions

Kesimpta OTHER

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.

Also known as: Ofatumumab

Kesimpta-exposed cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Pregnant women and their infant(s)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from 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.

You may qualify if:

• 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

You may not qualify if:

• Women meeting any of the following criteria will be excluded from the cohort study:
• Cohort 1: Kesimpta-Exposed Cohort
• Women who have enrolled in the Kesimpta cohort study with a previous pregnancy
• Women who have used Kesimpta for an indication other than a currently approved indication
• 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.
• Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
• 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)
• Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

University of California San Diego OTIS

La Jolla, California, 92093-0934, United States

RECRUITING

Related Links

• MotherToBaby Pregnancy Studies are observational studies coordinated at the University of California San Diego. Our studies are currently enrolling pregnant women in a study examining the use of medications to treat multiple sclerosis during pregnancy.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; mothertobaby@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: January 5, 2023
• Primary Completion (Estimated): February 28, 2033
• Study Completion (Estimated): February 28, 2033
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)