2023-505283-11-00招募中4 期
A phase IV, prospective, multicenter, open-label, mother-milk study to evaluate ofatumumab concentration in the breast milk of lactating women with relapsing forms of multiple sclerosis receiving ofatumumab (Kesimpta®)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 16
- 主要终点
- The concentration of ofatumumab in breast milk at the following timepoints: (pre-dose) on the day of the second (or any subsequent) maintenance dose, then 7, 14, 21 and (pre-dose) 28 days after the second (or any subsequent) maintenance dose.
研究概览
简要总结
Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •Active infections, including mastitis (participant may be included once the infection is resolved).
- •Participant with active hepatitis B disease prior to the initiation or re-initiation of ofatumumab. (Participant with positive hepatitis B serology should consult a liver disease expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.)
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •Any contraindication as per local label.
- •Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.
- •Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
- •Participant taking medications prohibited by the protocol (see Section 6.6.2) at screening.
- •Pregnant woman, confirmed by positive serum pregnancy test during screening.
- •Females 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.
- •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.
结局指标
主要结局
The concentration of ofatumumab in breast milk at the following timepoints: (pre-dose) on the day of the second (or any subsequent) maintenance dose, then 7, 14, 21 and (pre-dose) 28 days after the second (or any subsequent) maintenance dose.
The concentration of ofatumumab in breast milk at the following timepoints: (pre-dose) on the day of the second (or any subsequent) maintenance dose, then 7, 14, 21 and (pre-dose) 28 days after the second (or any subsequent) maintenance dose.
次要结局
- Proportion of participants with at least 1 sample with quantifiable ofatumumab concentrations in breast milk
- Maximum concentration (Cmax) of ofatumumab in breast milk over 28 days after the second (or any subsequent) maintenance dose.
- The exposure (area under the curve (AUC) of ofatumumab in milk over 28 days (from the second or any subsequent maintenance dose to the next maintenance dose after initiation or re-initiation of ofatumumab post-partum)
- Milk/Plasma (M/P) ratio of ofatumumab at 28 days after the second or any subsequent maintenance dose.
- Estimated relative infant dose (RID, %) over 28 days after the lactating mother receives second or subsequent maintenance dose
- Rate and nature of adverse events in the mothers treated with ofatumumab up to 12 months after ofatumumab treatment initiation/re-initiation
- Rate and nature of serious adverse events and any infections in the breast-fed infants of mothers up to 12 months after ofatumumab treatment initiation/re-initiation
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (16)
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