Ocrelizumab in Breastmilk
Condition: Multiple Sclerosis; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis
Study type: Observational

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.
    

Intervention name(s): Ocrelizumab
Intervention type(s): Drug
Intervention description(s): Receiving either 1infusion (600mg) or 2 infusions (300mg).
Other intervention name(s): ocrevus
Intervention MeSH terms: Ocrelizumab
Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      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)