Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multipl… (NCT06444113) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
United States, Germany24 participantsStarted 2024-11-25
Plain-language summary
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 participate
Age range18 Years – 100 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent must be obtained before any study assessment is performed.
✓. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
✓. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
✓. Participant has delivered term infant (at least 37 weeks gestation).
✓. Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study.
Exclusion criteria
✕. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
✕. Participant taking medications prohibited by the study protocol at screening.
✕. Pregnant woman, confirmed by positive serum pregnancy test during screening.
✕. Female of childbearing potential should use effective contraception as per local label.
✕. Participant has history of chronic alcohol abuse or drug abuse in the last year.
✕
What they're measuring
1
Concentration of ofatumumab in breast milk.
Timeframe: (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"
. Participant has any medical, obstetrical, psychiatric or other medical condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or confound the study assessment.
✕. Participant has history of breast implants, breast augmentation, or breast reduction surgery.
✕. Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.