Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis (NCT06444113)
A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
Who can join: Review the eligibility criteria below.
Location: UCSF — San Francisco, California
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- UCSF — San Francisco, California
- UC Health Neuroscience Ctr — Aurora, Colorado
- Northwestern Medicine Northwestern University — Winfield, Illinois
- Brigham and Womens Hospital — Brookline, Massachusetts
- Novartis Investigative Site — Munich, Bavaria
- Novartis Investigative Site — Bochum,
- Novartis Investigative Site — Hamburg,
- Novartis Investigative Site — Tübingen,
- Novartis Investigative Site — Foggia, FG
- Novartis Investigative Site — Bialystok,
- Novartis Investigative Site — Kielce,
- Novartis Investigative Site — Cambridge,
- Novartis Investigative Site — London,
- Novartis Investigative Site — Oxford,
- Novartis Investigative Site — Salford,
📞 Contact the Study Coordinator
Phone: (877) 827-3222
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.