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Research summary · AI summary · not yet reviewedHuman studyNot reportedTrial registry
Breastfeeding Individuals with RMS and BRIUMVI™
The study aims to determine how BRIUMVI™, a treatment for relapsing multiple sclerosis (RMS), is present in breast milk among breastfeeding participants. The key endpoint is to assess the concentration of BRIUMVI™ over time in breast milk.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding how BRIUMVI™ affects breast milk is important for breastfeeding mothers with RMS, as it addresses concerns about infant exposure to the medication.
What this does not prove
No results are available, and the plan for enrollment and study endpoints have not provided findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS, SPMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
Original sources
Supporting passages (8)
subjects"studyPopulation": "The study population will include breastfeeding individuals with RMS who are exposed to BRIUMVI™.",
speciesnull
research categories"briefSummary": "The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS)."
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\nMaternal Criteria:\n\n* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study\n* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)\n* Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose\n* Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning\n\nInfant Criteria:\n\n* Gestational age at delivery ≥35 weeks\n* Birthweight \\> 10th percentile\n* Weight \\> 10th percentile as reported by the mother at the time of enrollment\n\nExclusion Criteria:\n\nMaternal Criteria:\n\n* Any active infection or other condition that would prevent the individual from breastfeeding\n* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts\n* History of mastectomy\n* Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts\n* Current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye's syndrome), tetracyclines or fluoroquinolones\n\nInfant Criteria:\n\n\\- Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study",
primary endpoint"measure": "Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™",
findings"briefSummary": "The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS)."
limitationsNo results are posted.
limitationsPlanned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.