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    Clinical Trial Results:
    A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels in Infants of Lactating Women With CIS or MS Receiving Ocrelizumab

    Summary
    EudraCT number
    		 2021-000063-79
    Trial protocol
    		 ES   DE  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2025
    First version publication date
    12 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MN42989
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04998851
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4058
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    29 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2024
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) (in line with the locally approved indications) treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B-cell levels) in the infants.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    26
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    8
    Infants and toddlers (28 days-23 months)
    5
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 13 mother-infant pairs took part in the study across 7 sites in United States, Spain and United Kingdom. Data up to primary cut-off date is reported here. Final data will be reported 1 year after study completion date.

    Pre-assignment
    Screening details
    		 Lactating mothers with clinically isolated syndrome (CIS) or multiple sclerosis (MS), who, in consultation with their treating physician chose to continue or start postpartum treatment with commercial ocrelizumab were enrolled in this study.

    Period 1
    Period 1 title
    Treatment and Sampling Period (60 days)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mothers
    Arm description
    		 Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ocrelizumab
    Investigational medicinal product code
    RO4964913
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Mothers initiating, administered ocrelizumab 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1.

    Arm title
    		 Infants
    Arm description
    		 Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until 1 month (+30 days) after the first dose of measles, mumps, and rubella (MMR) vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+30 days) if MMR vaccine is not planned to be administered.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Mothers Infants
    Started
    13
    13
    Completed
    12
    12
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1
    Period 2
    Period 2 title
    Vaccination Period (11 Months)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mothers
    Arm description
    		 Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ocrelizumab
    Investigational medicinal product code
    RO4964913
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Mothers initiating, administered ocrelizumab, 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1.

    Arm title
    		 Infants
    Arm description
    		 Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until 1 month (+30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+30 days) if MMR vaccine is not planned to be administered.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Mothers Infants
    Started
    12
    12
    Completed
    6
    6
    Not completed
    6
    6
         Consent withdrawn by subject
    2
    1
         Reason Not Specified
    -
    1
         Ongoing in the study
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mothers
    Reporting group description
    		 Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

    Reporting group title
    Infants
    Reporting group description
    		 Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until 1 month (+30 days) after the first dose of measles, mumps, and rubella (MMR) vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+30 days) if MMR vaccine is not planned to be administered.

    Reporting group values
    		 Mothers Infants Total
    Number of subjects
    		 13 13 26
    Age categorical
    Units: Subjects
        Pre-term newborn - gestational age < 37 wk
    		 0 0 0
        Newborns (0-27 days)
    		 0 8 8
        Infants and toddlers (28 days-23 months)
    		 0 5 5
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 13 0 13
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 35.0 (30 to 40) 0.02 (0.00 to 0.33) -
    Sex: Female, Male
    Units: participants
        Female
    		 13 6 19
        Male
    		 0 7 7

    End points

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    End points reporting groups
    Reporting group title
    Mothers
    Reporting group description
    		 Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

    Reporting group title
    Infants
    Reporting group description
    		 Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until 1 month (+30 days) after the first dose of measles, mumps, and rubella (MMR) vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+30 days) if MMR vaccine is not planned to be administered.
    Reporting group title
    Mothers
    Reporting group description
    		 Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

    Reporting group title
    Infants
    Reporting group description
    		 Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until 1 month (+30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+30 days) if MMR vaccine is not planned to be administered.

    Primary: Percentage of Infants with B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother’s First Ocrelizumab Postpartum Infusion

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    End point title
    		 Percentage of Infants with B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother’s First Ocrelizumab Postpartum Infusion [1] [2]
    End point description
    Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022. Full Analysis Set Infants (FASI) included all the infants of women in the Full Analysis Set Mothers (FASM) population. Number analyzed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    At Day 30
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analysis was planned for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    10
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 30.85)
    No statistical analyses for this end point

    Primary: Estimated Average Oral Daily Infant Dosage (ADID)

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    End point title
    		 Estimated Average Oral Daily Infant Dosage (ADID) [3] [4]
    End point description
    ADID was calculated as the arithmetic mean of the mother's daily ocrelizumab milk concentration (micrograms/milliliters [µg/mL]) over 60 days post-ocrelizumab infusion 1 multiplied by an estimated infant milk intake of 150 milliliters/kilograms/day (mL/kg/day) and based on the weight [kilograms (kg)] recorded at the Day 30 visit. Ocrelizumab concentrations reported as below the lower limit of quantification [LLQ=160 nanograms/millilitres (ng/mL)] are imputed to zero for the calculation ADID. Pharmacokinetic Analysis Set Mothers (PASM) included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Primary
    End point timeframe
    Up to Day 60
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analysis was planned for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: micrograms (µg)
        arithmetic mean (confidence interval 95%)
    64.50 (21.415 to 107.587)
    No statistical analyses for this end point

    Secondary: Absolute CD19+ B Cell Count in the Infant

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    End point title
    		 Absolute CD19+ B Cell Count in the Infant [5]
    End point description
    Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). FASI included all the infants of women in the FASM population. Number analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    At Day 30
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    10
    Units: cells per microliter (cells/µL)
        median (full range (min-max))
    1431.50 (869.0 to 2241.0)
    No statistical analyses for this end point

    Secondary: Percentage of CD19+ B Cell in the Infant

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    End point title
    		 Percentage of CD19+ B Cell in the Infant [6]
    End point description
    Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). FASI included all the infants of women in the FASM population. Number analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    At Day 30
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    10
    Units: percentage of cells
        median (full range (min-max))
    21.80 (10.0 to 31.7)
    No statistical analyses for this end point

    Secondary: Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk

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    End point title
    		 Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk [7]
    End point description
    PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Secondary
    End point timeframe
    One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: micrograms/millilitres*day (μg/mL*day)
        arithmetic mean (standard deviation)
    3.98 ( 4.93 )
    No statistical analyses for this end point

    Secondary: Average Concentration of Ocrelizumab in Breastmilk (Cmean)

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    End point title
    		 Average Concentration of Ocrelizumab in Breastmilk (Cmean) [8]
    End point description
    PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Secondary
    End point timeframe
    One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: μg/mL
        arithmetic mean (standard deviation)
    0.074 ( 0.077 )
    No statistical analyses for this end point

    Secondary: Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk

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    End point title
    		 Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk [9]
    End point description
    PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Secondary
    End point timeframe
    One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: μg/mL
        arithmetic mean (standard deviation)
    0.18 ( 0.15 )
    No statistical analyses for this end point

    Secondary: Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk

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    End point title
    		 Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk [10]
    End point description
    PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Secondary
    End point timeframe
    One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: days
        median (full range (min-max))
    3.97 (0.00 to 59.9)
    No statistical analyses for this end point

    Secondary: Estimated Maximum Oral Daily Infant Dosage (MDID)

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    End point title
    		 Estimated Maximum Oral Daily Infant Dosage (MDID) [11]
    End point description
    MDID was calculated at the subject level as the peak ocrelizumab milk concentration (μg/mL) multiplied by an estimated infant milk intake of 150 mL/kg/day measured over 60 days after the mother’s first postpartum ocrelizumab infusion. PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Secondary
    End point timeframe
    Up to Day 60
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: µg
        arithmetic mean (standard deviation)
    153.20 ( 137.15 )
    No statistical analyses for this end point

    Secondary: Average Relative Infant Dose (RID)

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    End point title
    		 Average Relative Infant Dose (RID) [12]
    End point description
    Average RID over 60 days was calculated as the ADID (mg/kg/day) divided by the maternal dosage (mg/kg/day) over 60 days multiplied by 100. PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
    End point type
    Secondary
    End point timeframe
    Up to Day 60
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    12
    Units: percentage
        arithmetic mean (standard deviation)
    0.50 ( 0.58 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Ocrelizumab in the Infant at Day 30

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    End point title
    		 Serum Concentration of Ocrelizumab in the Infant at Day 30 [13]
    End point description
    Serum concentration of ocrelizumab in the infant measured at Day 30 after the mother’s first ocrelizumab postpartum infusion. Concentrations reported as below the lower limit of quantification (LLQ=156 ng/mL) are set to zero for calculation of summary statistics. Pharmacokinetic Analysis Set Infants (PASI) included all infants in the FASI with a serum sample to allow measurement of ocrelizumab concentration. 9999 indicates that the mean and SD were not evaluable as samples were below the limit of quantification (BLQ).
    End point type
    Secondary
    End point timeframe
    At Day 30
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    9
    Units: µg/mL
        arithmetic mean (standard deviation)
    9999 ( 9999 )
    No statistical analyses for this end point

    Secondary: Percentage of Mothers With of Adverse Events (AEs)

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    End point title
    		 Percentage of Mothers With of Adverse Events (AEs) [14]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. The data collection is ongoing, and results will be disclosed within 1 year from the study completion date (SCD).
    End point type
    Secondary
    End point timeframe
    Up to 16 months
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the mothers only.
    End point values
    		 Mothers
    Number of subjects analysed
    0 [15]
    Units: percentage of mothers
    Notes
    [15] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Percentage of Infants With Positive Humoral Response to DTP Vaccine

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    End point title
    		 Percentage of Infants With Positive Humoral Response to DTP Vaccine [16]
    End point description
    Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) will be presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for DTP vaccine are as follows: Anti-Diphtheria IgG(-70)CL and Anti-Tetanus Toxoid IgG(-70)RUO: ≥ 0.01 IU/mL; Bordetella pertussis antibodies, IgG: > 1.04 cut-off index (COI). The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [17]
    Units: percentage of participants
        number (not applicable)
    Notes
    [17] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Mean Titers of Antibody Immune Responses to Diphtheria-Tetanus-Pertussis (DTP) Vaccine

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    End point title
    		 Mean Titers of Antibody Immune Responses to Diphtheria-Tetanus-Pertussis (DTP) Vaccine [18]
    End point description
    The immune response to DTP vaccine will be assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [19]
    Units: titers
        arithmetic mean (standard deviation)
    ( )
    Notes
    [19] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Percentage of Infants With Positive Humoral Response to MMR Vaccination

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    End point title
    		 Percentage of Infants With Positive Humoral Response to MMR Vaccination [20]
    End point description
    Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) will be presented for each immunoglobulin G (IgG) antibody titer. Seroprotective titer based on vaccine tests for MMR vaccine are as follows: Anti-Measles Vir IgG(-70)CL: ≥ 120 milli-international units/milliliter (mIU/mL); Anti-MumpsAT Vir iGG(-70)CL: ≥ 17 units per milliliters (U/mL); Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 international units/milliliters (IU/mL). The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [21]
    Units: titers
        arithmetic mean (standard deviation)
    ( )
    Notes
    [21] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Mean Titers of Antibody Immune Responses to Measles, Mumps, and Rubella (MMR) Vaccination

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    End point title
    		 Mean Titers of Antibody Immune Responses to Measles, Mumps, and Rubella (MMR) Vaccination [22]
    End point description
    The immune response to MMR vaccine will be assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [23]
    Units: titers
        arithmetic mean (standard deviation)
    ( )
    Notes
    [23] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Percentage of Infants With of Adverse Events (AEs)

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    End point title
    		 Percentage of Infants With of Adverse Events (AEs) [24]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 16 months
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [25]
    Units: percentage of infants
    Notes
    [25] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Mean Titers of Antibody Immune Responses to Hepatitis B Vaccine (HBV)

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    End point title
    		 Mean Titers of Antibody Immune Responses to Hepatitis B Vaccine (HBV) [26]
    End point description
    The immune response to HBV vaccine will be assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [27]
    Units: titers
        arithmetic mean (standard deviation)
    ( )
    Notes
    [27] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Percentage of Infants With Positive Humoral Response to Hib Vaccine

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    End point title
    		 Percentage of Infants With Positive Humoral Response to Hib Vaccine [28]
    End point description
    Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) will be presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [29]
    Units: percentage of participants
        number (not applicable)
    Notes
    [29] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Mean Titers of Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccine

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    End point title
    		 Mean Titers of Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccine [30]
    End point description
    The immune response to Hib vaccine will be assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [31]
    Units: titers
        arithmetic mean (standard deviation)
    ( )
    Notes
    [31] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)

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    End point title
    		 Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) [32]
    End point description
    The immune response to PCV-13 vaccine will be assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [33]
    Units: titers
        arithmetic mean (standard deviation)
    ( )
    Notes
    [33] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Percentage of Infants With Positive Humoral Response to HBV

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    End point title
    		 Percentage of Infants With Positive Humoral Response to HBV [34]
    End point description
    Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) will be presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for HBV vaccine are as follows: Anti-HBs: ≥ 10 mIU/mL. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [35]
    Units: percentage of participants
        number (not applicable)
    Notes
    [35] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Secondary: Percentage of Infants With Positive Humoral Response to PCV-13

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    End point title
    		 Percentage of Infants With Positive Humoral Response to PCV-13 [36]
    End point description
    Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) will be presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for PCV-13 vaccine are as follows: 13 Valent anti-pneumococcal antibody panel: ≥ 0.35 µg/ml. The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports data for the infants only.
    End point values
    		 Infants
    Number of subjects analysed
    0 [37]
    Units: percentage of participants
        number (not applicable)
    Notes
    [37] - The data collection is ongoing, and results will be disclosed within 1 year from the SCD.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Mothers: Up to approximately 73.3 weeks Infants: Up to approximately 62.7 weeks
    Adverse event reporting additional description
    SAFM included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab. SAFI included all infants of women in FASM population. Data up to primary cut-off date is reported here. Final data will be reported 1 year after study completion date.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Infants
    Reporting group description
    		 Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered.

    Reporting group title
    Mothers
    Reporting group description
    		 Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

    Serious adverse events
    		 Infants Mothers
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infants Mothers
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 13 (84.62%)
    10 / 13 (76.92%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Haemangioma
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1
    Pain
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Throat irritation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Multiple sclerosis pseudo relapse
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Eye disorders
    Strabismus
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Teething
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Oral pruritus
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin fissures
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Dermatitis diaper
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Infected cyst
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Mastitis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 13 (15.38%)
         occurrences all number
    3
    3
    Oral herpes
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Fungal infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    3
    Ear infection
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    4 / 13 (30.77%)
    6 / 13 (46.15%)
         occurrences all number
    5
    6
    Bronchiolitis
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Rhinovirus infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    Suspected COVID-19
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2022
    1. A note on referral to sites was added, to allow referral of potentially eligible women to study sites. Women could be referred to study sites; and the possibility of home-based study visits was extended to all visits (conducted by a mobile nurse, and by the investigator using telemedicine [i.e., remotely]). 2. Woman agreed to use acceptable contraceptive methods or alternative methods during the study as described below and, if applicable, upon study treatment discontinuation, as defined by the local prescribing information.
    05 Jun 2023
    1. The secondary objectives were amended to include the evaluation of the relative exposure as measured by the RID to ocrelizumab in infants of lactating women with CIS or MS receiving ocrelizumab postpartum. 2. The sample size was reduced from at least 20 to at least 10 women with CIS or MS. 3. The total length of the study was increased from approximately 2 years to approximately 3 years, due to the extension of the enrolment period from approximately 8 months to approximately 21 months. 4. The list of antibody (Ab) titers of responses to vaccines administered as per local practice, had been updated to detail that the following were included: antimeasles Ab IgG, anti-rubella Ab IgG, anti-mumps Ab IgG, PCV-13 Ab (all serotypes), anti-tetanus toxoid IgG, anti-diphtheria IgG, Bordetella pertussis Ab IgG, hepatitis B surface Ab, Hemophilus influenza B IgG.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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