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Ocrelizumab in Breastmilk

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ClinicalTrials.gov Identifier: NCT04387110
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Clinically Isolated Syndrome Drug: Ocrelizumab

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monoclonal Antibodies in Mothers' Milk and Infants: Ocrelizumab in Breastmilk
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : July 19, 2021
Estimated Study Completion Date : December 19, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Group/Cohort Intervention/treatment
Ocrelizumab
Women receiving treatment for multiple sclerosis with ocrelizumab infusion between 2 and 36 weeks postpartum.
Drug: Ocrelizumab
Receiving either 1infusion (600mg) or 2 infusions (300mg).
Other Name: ocrevus




Primary Outcome Measures :
  1. Determine levels of ocrelizumab in the breastmilk of women with MS [ Time Frame: 12 months ]
    Levels of ocrelizumab (μg/mL) in the breastmilk of women at the selected timepoints before and after infusion (hour 8, hour 24, day 7, day 20, day 30, day 60, and day 90). If receiving two infusions the samples will be as follows: pre-infusion, hour 8, hour 24, day 7, and day 14 after infusion 1(prior to infusion 2); then post infusion 2, at hour 8, hour 24, day 7, day 20, day 30, day 60, and day 90.

  2. Determine time to peak levels of ocrelizumab in the breastmilk of women with MS. [ Time Frame: 12 months ]
    Based on analysis of levels of ocrelizumab (μg/mL) in the breastmilk of women at the selected timepoints before and after infusion (hour 8, hour 24, day 7, day 20, day 30, day 60, and day 90). If receiving two infusions the samples will be as follows: pre-infusion, hour 8, hour 24, day 7, and day 14 after infusion 1(prior to infusion 2); then post infusion 2, at hour 8, hour 24, day 7, day 20, day 30, day 60, and day 90. The average peak level of ocrelizumab concentration will be determined.

  3. Determine predictors of ocrelizumab levels in breastmilk. [ Time Frame: 12 months ]
    The following predictors will be assessed in relation to level of detectable ocrelizumab in breastmilk: ocrelizumab dosing (300 vs. 600mg), maternal age and parity, introduction of solid foods, and other clinical factors.


Secondary Outcome Measures :
  1. Obtain information on newborn adjusted length until 12 months of life. [ Time Frame: 12 months ]
    Newborn adjusted length (in cm) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

  2. Obtain information on newborn weight until 12 months of life. [ Time Frame: 12 Months ]
    Newborn weight (in kg) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

  3. Obtain information on newborn head circumference until 12 months of life. [ Time Frame: 12 Months ]
    Newborn head circumference (in cm) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

  4. Obtain information on newborn infections until 12 months of life. [ Time Frame: 12 Months ]
    Newborn infections will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

  5. Obtain information on newborn vaccines until 12 months of life. [ Time Frame: 12 Months ]
    Newborn vaccine completed and scheduled vaccines will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.

  6. Obtain information on newborn developmental milestones until 12 months of life. [ Time Frame: 12 Months ]
    The Ages and Stages Questionnaire, third edition, (ASQ-3) will be completed by participating mothers at the following timepoints postpartum, to determine the developmental age of infants: 2 months, 4 months, 6 months, 8 months, 10 months and 12 months. The questionnaire scores 5 areas of development: Communication, Gross Motor, Fine Motor, Problem Solving and Personal-Social. Cumulative scores range from 0 to 60. Higher scores indicate more positive outcomes. Each version of the ASQ-3 has different cutoff scores that indicate whether the child's development appears to be on schedule, requires monitoring or requires further assessment.


Biospecimen Retention:   Samples With DNA

Breastmilk-Breastmilk will be serially sampled prior to and after the first infusion(s) postpartum according to the following schedule:

  • 600mg infusion x1: before infusion and at 8H, 24H, 7D, 20D, 30D, 60D, and 90D post
  • 300mg infusion x2: 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

Blood (serum)- Samples will be collected to determine maternal serum concentration of ocrelizumab relative to breastmilk samples at the following timepoints:

  • 600mg infusion x1: 24H and 20D post infusion
  • 300mg infusion x2: 24H and 14D (post infusion 1) and 24H and 20D (post infusion 2)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants will be identified via self referral from study advertisements (via the National MS Society and clinicaltrials.gov) or referred by clinician at the UCSF MS Center.

Clinicians outside of UCSF will also be invited to refer eligible patients to the study by providing study team contact information.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387110


Contacts
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Contact: Annika Anderson, BA (415) 353-8903 annika.anderson@ucsf.edu
Contact: William Rowles, BA (415) 502-7209 William.Rowles@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Annika Anderson, BA    415-353-8903    annika.anderson@ucsf.edu   
Principal Investigator: Riley Bove, MD, MSc         
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
Investigators
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Principal Investigator: Riley Bove, MD, MSc University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04387110    
Other Study ID Numbers: 17-22422
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs