Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT06444113
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria:<br><br> 1. Written informed consent must be obtained before any study assessment is performed.<br><br> 2. Participant is female with a relapsing form of MS and at least 18 years of age at<br> the time of providing consent.<br><br> 3. Participant must be postpartum at the time of enrollment, plan to be exclusively<br> breastfeeding and willing to provide breast milk samples.<br><br> 4. Participant has delivered term infant (at least 37 weeks gestation).<br><br> 5. Participant must plan to initiate or re-initiate or have initiated or re-initiated<br> treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be<br> treated with ofatumumab and to breastfeed is made in accordance with the treating<br> physician and must be completely independent of the decision to participate in this<br> study.<br><br>Exclusion Criteria:<br><br> 1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30<br> days or until the expected pharmacodynamic effect has returned to baseline,<br> whichever is longer.<br><br> 2. Participant taking medications prohibited by the study protocol at screening.<br><br> 3. Pregnant woman, confirmed by positive serum pregnancy test during screening.<br><br> 4. Female of childbearing potential should use effective contraception as per local<br> label.<br><br> 5. Participant has history of chronic alcohol abuse or drug abuse in the last year.<br><br> 6. Participant has any medical, obstetrical, psychiatric or other medical condition<br> that, in the opinion of the Investigator, can jeopardize or would compromise the<br> subject's ability to participate in this study or confound the study assessment.<br><br> 7. Participant has history of breast implants, breast augmentation, or breast reduction<br> surgery.<br><br> 8. Participant has received anti-CD20 agents during the second and third trimesters of<br> pregnancy.<br><br> 9. Active infections, including mastitis (participant may be included once the<br> infection is resolved).<br><br> 10. Prior or current history of primary or secondary immunodeficiency, or participant in<br> an otherwise severely immunocompromised state.<br><br> 11. Participant with active hepatitis B disease prior to the initiation or re-initiation<br> of ofatumumab. (Participant with positive hepatitis B serology should consult a<br> liver disease medical standards to prevent hepatitis B reactivation.)<br><br> 12. History of malignancy of any organ system (other than localized basal cell carcinoma<br> of the skin or in situ cervical cancer), treated or untreated, within the past 5<br> years, regardless of whether there is evidence of local recurrence or metastases.<br><br> 13. Any contraindication as per local label.<br><br> 14. Participant who has an infant with any abnormality that may interfere with<br> breastfeeding or confound the study assessment in the opinion of the Investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concentration of ofatumumab in breast milk.
- Secondary Outcome Measures
Name Time Method Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum;Estimation of relative infant dose of ofatumumab;Safety data collected in lactating women receiving ofatumumab and their breastfed infants;Plasma Pharmacokinetics of OMB157(Cmax);Plasma Pharmacokinetics of OMB157(AUC);Plasma Pharmacokinetics of OMB157 (M/P Ratio)