🏛️ Verified NIH Record • Updated 2025-01-12

Kesimpta (Ofatumumab) Pregnancy Registry (NCT05634967)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (28 items).

Location: University of California San Diego OTIS — La Jolla, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: 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.
  • New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • University of California San Diego OTIS — La Jolla, California

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗