Kesimpta (Ofatumumab) Pregnancy Registry

Part of paid clinical trials in La Jolla, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05634967
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jan 5, 2023
Status verified
Jan 2025
Primary completion
Feb 28, 2033
Completion
Feb 28, 2033

Study Design

Enrollment
725 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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.
  • Arm: Kesimpta-exposed cohort
    women and infants who are exposed to Kesimpta during pregnancy to treat MS.

Primary Outcome Measure

Number of participants with major structural defects [ Time Frame: Up to 21 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego OTISLa JollaCalifornia92093-0934
877-311-8972
Diana Johnson (PRINCIPAL_INVESTIGATOR)

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University of California San Diego OTIS· La Jolla, CA

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