No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
16 (estimated)
Sponsor
TG Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for breastfeeding women who are being treated with BRIUMVI™ for relapsing multiple sclerosis. Participants will provide breast milk for testing during the study.
Are You a Good Fit for This Trial?
Must not be takingAspirinTetracyclinesFluoroquinolones
You may be able to join if
I have relapsing multiple sclerosis.
I have chosen to be treated with BRIUMVI™.
I am willing to breastfeed or pump regularly during the study.
I plan to continue giving my baby breast milk throughout the study.
My baby was delivered at 35 weeks or later.
My baby weighs more than the 10th percentile.
I am not weaning my baby.
You may not be able to join if
I have an active infection that prevents breastfeeding.
I have had breast surgery that affects breastfeeding.
I have had a mastectomy.
I have signs of mastitis or another significant infection.
I am currently using drugs known to transfer to breast milk and may harm my baby.
My baby has a significant health condition or abnormality.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
Maternal Criteria:
* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study
* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary p…
Inclusion Criteria:
Maternal Criteria:
* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study
* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)
* 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
* Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
Infant Criteria:
* Gestational age at delivery ≥35 weeks
* Birthweight \> 10th percentile
* Weight \> 10th percentile as reported by the mother at the time of enrollment
Exclusion Criteria:
Maternal Criteria:
* Any active infection or other condition that would prevent the individual from breastfeeding
* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
* History of mastectomy
* 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
* 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
Infant Criteria:
\- 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
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