Ocrelizumab in Breastmilk

NCT ID: NCT04387110

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2022-03-01

Brief Summary

The goal of the current project is to measure the levels of ocrelizumab in the breastmilk of women with multiple sclerosis (MS) and clinically isolated syndrome (CIS) who are postpartum, and to collect information on 12-month infant development outcomes (length, weight, head circumference, infections) in their offspring.

This study will fill a significant unmet need as many women with MS at high risk for postpartum relapses are not effectively treated for their MS in the postpartum period due to lack of information about the presence, concentration and effects of medications in breastmilk.

Detailed Description

Levels of ocrelizumab in breastmilk will be serially evaluated across one drug half-life from women with MS and CIS who are postpartum and lactating at the time of the infusion (whether or not they plan to continue to breastfeed their baby after the infusion). The timeline for breastmilk sample is dependent on infusion schedule and dosing if receiving 600mg infusion x1, collection will occur: before infusion and at 8H, 24H, 7D, 20D, 30D, 60D, and 90D post infusion; if receiving 300mg infusion x2 collection will occur: before infusion 1, at 8H, 24H, 7D, and 14D (before infusion 2) after infusion 1 and after infusion 2 at 8H, 24H, 7D, 20D, 30D, 60D, and 90D in 20. Blood samples to determine serum concentration of ocrelizumab will be collected, when possible, at the 24-hour, 14 day (if receiving 300mg infusion x2), and 20D timepoint(s). Both women continuing to breastfeed their infant post-infusion and those that chose to discontinue will be included in the study.

In order to ensure broad collaboration as well as rapid recruitment, samples will be collected from patients fitting eligibility criteria upon referral to our study by other investigators.

Conditions

Multiple Sclerosis; Clinically Isolated Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ocrelizumab

Women receiving treatment for multiple sclerosis with ocrelizumab infusion between 2 and 36 weeks postpartum.

Ocrelizumab

Intervention Type: DRUG

Receiving either 1infusion (600mg) or 2 infusions (300mg).

Interventions

Ocrelizumab

Receiving either 1infusion (600mg) or 2 infusions (300mg).

Intervention Type: DRUG

Other Intervention Names

ocrevus

Eligibility Criteria

Inclusion Criteria

• Women between the ages of 18 and 64 that carry a diagnosis of Clinically Isolated Syndrome or Multiple Sclerosis (based on the 2010 McDonald Criteria).
• Participants must be pregnant, contemplating pregnancy or postpartum at the time of enrollment.
• Participants must be receiving treatment with ocrelizumab infusion between 2 and 36 weeks postpartum (300mg x2 or 600mg x1).
• Participants must be willing to provide breastmilk samples before and after their first and, if applicable, second ocrelizumab infusions postpartum.
• A signed informed consent and HIPAA authorization form is required for participation.

Exclusion Criteria

• Patients unable to provide informed consent.
• Patients unable or unwilling to provide breast milk samples for analysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riley Bove, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Genentech. (2011). Prescribing Information. [PDF File]. Retrieved from https://www.gene.com/download/pdf/ocrevus_prescribing.pdf

Reference Type: BACKGROUND

Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. doi: 10.1053/j.gastro.2018.05.040. Epub 2018 May 30.

Reference Type: BACKGROUND

PMID: 29857090 (View on PubMed)

Hale TW, Rowe HE. Medications and mothers' milk. 16th ed. Amarillo (TX): Hale Publishing; 2014

Reference Type: BACKGROUND

Krysko KM, LaHue SC, Anderson A, Rutatangwa A, Rowles W, Schubert RD, Marcus J, Riley CS, Bevan C, Hale TW, Bove R. Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 12;7(1):e637. doi: 10.1212/NXI.0000000000000637. Print 2020 Jan.

Reference Type: BACKGROUND

PMID: 31719115 (View on PubMed)

Other Identifiers

17-22422

Identifier Type: -

Identifier Source: org_study_id