RECRUITING

Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

Conditions

Multiple Sclerosis Lactating women,multiple sclerosis (MS)ofatumumab milk concentration breastfed infant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.

Official Title

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

Quick Facts

Study Start:2024-08-30

Study Completion:2026-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06444113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent must be obtained before any study assessment is performed. 2. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent. 3. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples. 4. Participant has delivered term infant (at least 37 weeks gestation). 5. 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.	1. 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. 2. Participant taking medications prohibited by the study protocol at screening. 3. Pregnant woman, confirmed by positive serum pregnancy test during screening. 4. Female of childbearing potential should use effective contraception as per local label. 5. Participant has history of chronic alcohol abuse or drug abuse in the last year. 6. 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. 7. Participant has history of breast implants, breast augmentation, or breast reduction surgery. 8. Participant has received anti-CD20 agents during the second and third trimesters of pregnancy. 9. Active infections, including mastitis (participant may be included once the infection is resolved). 10. Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state. 11. 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 medical standards to prevent hepatitis B reactivation.) 12. 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. 13. Any contraindication as per local label. 14. Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.

Inclusion Criteria

Exclusion Criteria

1. Written informed consent must be obtained before any study assessment is performed.
2. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
3. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
4. Participant has delivered term infant (at least 37 weeks gestation).
5. 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.

1. 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.
2. Participant taking medications prohibited by the study protocol at screening.
3. Pregnant woman, confirmed by positive serum pregnancy test during screening.
4. Female of childbearing potential should use effective contraception as per local label.
5. Participant has history of chronic alcohol abuse or drug abuse in the last year.
6. 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.
7. Participant has history of breast implants, breast augmentation, or breast reduction surgery.
8. Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.
9. Active infections, including mastitis (participant may be included once the infection is resolved).
10. Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
11. 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 medical standards to prevent hepatitis B reactivation.)
12. 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.
13. Any contraindication as per local label.
14. Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Locations (Sites)

UCSF .

San Francisco, California, 94115

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30

Study Completion Date2026-02-02

Study Record Updates

Study Start Date2024-08-30

Study Completion Date2026-02-02

Terms related to this study

Keywords Provided by Researchers

Lactating women,
multiple sclerosis (MS)
ofatumumab
milk concentration
breastfed infant

Additional Relevant MeSH Terms

Multiple Sclerosis