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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Milk Collection | Breast milk will be collected of participants with relapsing forms of multiple sclerosis (RMS) who are receiving BRIUMVI™ therapeutically for up to 24 hours to determine concentration of BRIUMVI™ in milk samples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™ | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 | |
| Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™ | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 | |
| Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™ | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 | |
| Maximum Observed Milk Concentration of BRIUMVI™ (Cmax) | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 | |
| Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™ | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90 | |
| Time of Cmax (Tmax) of BRIUMVI™ in Milk | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount Excreted (Ae) of BRIUMVI™ in Milk | Total amount of drug excreted in milk (mg) as: Σ(total drug concentration in each milk collection x milk volume in each milk collection) | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 |
| Fraction of Dose Excreted (Fe) in Milk of BRIUMVI™ |
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Inclusion Criteria:
Maternal Criteria:
Infant Criteria:
Exclusion Criteria:
Maternal Criteria:
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
The study population is restricted to breastfeeding participants.
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The study population will include breastfeeding individuals with RMS who are exposed to BRIUMVI™.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PROVIDE Virtual Research Coordination Center | Contact | 1-877-296-4411 | briumvi_lactationstudy@ppd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PROVIDE Virtual Research Coordination Center | Recruiting | San Francisco | California | 94158 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Fraction of dose excreted in milk calculated as Ae/Administered dose |
| Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 |
| Infant Dose (ID) of BRIUMVI™ | Infant dose = Ʃ drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection. | Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90 |
| Relative Infant Dose (RID) of BRIUMVI™ | Relative infant dose = infant dose milligrams/kilograms (mg/kg)/ [Maternal Dose (mg)/Maternal Bodyweight (kg)] multiplied by 100 | Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90 |
| Number of Infants with Adverse Events | From the signing the inform consent form up to approximately 3 months after the index infusion |
| PROVIDE Virtual Research Coordination Center | Recruiting | Smyrna | Georgia | 30080 | United States |
| TG Therapeutics Investigational Trial Site | Recruiting | Boston | Massachusetts | 02115 | United States |
| PROVIDE Virtual Research Coordination Center | Recruiting | Wilmington | North Carolina | 28401-3331 | United States |
| PROVIDE Virtual Research Coordination Center | Recruiting | Nashville | Tennessee | 37215 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |