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RecruitingMultiple SclerosisPregnancy

Kesimpta (Ofatumumab) Pregnancy Registry

Eligible age

18–100 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: Novartis Pharmaceuticals

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
  • ✓ 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

You may not qualify if…

  • ✕ 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

Where it's recruiting

California

La Jolla

Source: ClinicalTrials.gov · NCT05634967 · last updated 2025-01-14