Trial Outcomes & Findings for A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy (NCT NCT04998812)

NCT ID: NCT04998812

Last Updated: 2025-09-04

Results Overview

The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: At Week 6 of infant's life
• Results posted on: 2025-09-04

Participant Flow

35 pregnant women (with singleton pregnancy) were enrolled in the study across 10 centers in the United States, Germany, France, Switzerland and Spain. An Informed Consent Form (ICF) for participation of the maternal subject and her unborn was signed and dated by the subject. Where applicable, the written ICF with respect to the infant was also signed and dated by the holder of parental rights as designated by the maternal subject. The study is still ongoing.

Pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) who were exposed accidentally or as part of routine clinical practice to commercial ocrelizumab up to 6 months before the last menstrual period (LMP) or during the first trimester of pregnancy were enrolled & potential placental transfer of ocrelizumab in infants was observed.

Participant milestones

Measure	Women Pregnant women receiving commercial ocrelizumab intravenously (IV) either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.	Infants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 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.
Pregnancy and Early Post-Partum Period STARTED	35	35
Pregnancy and Early Post-Partum Period Subject Gave Birth/Infant Was Born	35	35
Pregnancy and Early Post-Partum Period COMPLETED	33	34
Pregnancy and Early Post-Partum Period NOT COMPLETED	2	1
Vaccination Period STARTED	33	34
Vaccination Period COMPLETED	10	11
Vaccination Period NOT COMPLETED	23	23

Reasons for withdrawal

Measure	Women Pregnant women receiving commercial ocrelizumab intravenously (IV) either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.	Infants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 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.
Pregnancy and Early Post-Partum Period Participant switches to another treatment of MS	1	0
Pregnancy and Early Post-Partum Period Lost to Follow-up	1	0
Pregnancy and Early Post-Partum Period Other	0	1
Vaccination Period Ongoing in study	23	23

Baseline Characteristics

A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

Baseline characteristics by cohort

Measure	Women n=35 Participants Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.	Infants n=35 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 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.	Total n=70 Participants Total of all reporting groups
Age, Customized Preterm newborn infants (gestational age <37 weeks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	35 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	35 Participants n=5 Participants	0 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	22 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 6 of infant's life

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.

The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.

Outcome measures

Measure	Infants n=34 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN)	0 percentage of participants Interval 0.0 to 10.28

SECONDARY outcome

Timeframe: At Week 6 of infant's life

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.

Outcome measures

Measure	Infants n=34 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Absolute CD19+ B Cell Count in the Infant Potentially Exposed to Ocrelizumab During Pregnancy	1170.00 cells per microliter (cells/µL) Interval 269.0 to 2408.0

SECONDARY outcome

Timeframe: At Week 6 of infant's life

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.

Outcome measures

Measure	Infants n=34 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Percentage of CD19+ B Cell in the Infant Potentially Exposed to Ocrelizumab During Pregnancy	19.20 percentage of cells Interval 5.2 to 35.3

SECONDARY outcome

Timeframe: Within 1 hour after delivery (at birth Day 1)

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy.

Serum ocrelizumab concentrations were measured in the umbilical cord blood at birth (within 1 hour after delivery) to evaluate whether there was placental transfer of ocrelizumab from the mother to the infant. At delivery, blood samples from the umbilical cord were collected. Ocrelizumab serum concentration below the lower limit of quantification (LLOQ =156 ng/ml) was set to zero.

Outcome measures

Measure	Infants n=35 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth	0.00 nanograms/milliliter (ng/mL) Interval 0.0 to 694.0

SECONDARY outcome

Timeframe: At Week 6 of infant's life

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.

Serum ocrelizumab concentrations were measured were measured at 6 weeks of the infants life to evaluate whether there was placental transfer of ocrelizumab from the mother to the infant. Serum samples from the infant were collected.

Outcome measures

Measure	Infants n=33 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Serum Concentration of Ocrelizumab in the Infant at Week 6 of Life	0.00 ng/mL Interval 0.0 to 263.0

SECONDARY outcome

Timeframe: Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth Day 1)

Population: FASW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Serum concentration of ocrelizumab in the mother during pregnancy (time frame of blood sampling: Week 24-30, Week 35) and at delivery (time frame of blood sampling: within 24 hours after delivery). Ocrelizumab serum concentration below the lower limit of quantification (LLOQ =156 ng/ml) was set to zero.

Outcome measures

Measure	Infants n=35 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Serum Concentration of Ocrelizumab in the Mother Baseline - Gestational Weeks 24-30	0.00 ng/mL Interval 0.0 to 9090.0
Serum Concentration of Ocrelizumab in the Mother Gestational Week 35	0.00 ng/mL Interval 0.0 to 787.0
Serum Concentration of Ocrelizumab in the Mother At Delivery	0.00 ng/mL Interval 0.0 to 382.0

SECONDARY outcome

Timeframe: Up to 17 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 17 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At birth (Day 1)

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy.

Day 1 refers to the time an infant's birth.

Outcome measures

Measure	Infants n=35 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Infant Characteristics at Birth: Body Weight	3.46 kilogram (kg) Standard Deviation 0.43

SECONDARY outcome

Timeframe: At birth (Day 1)

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.

Day 1 refers to the time an infant's birth.

Outcome measures

Measure	Infants n=30 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Infant Characteristics at Birth: Head Circumference	35.08 centimeter (cm) Standard Deviation 1.15

SECONDARY outcome

Timeframe: At birth (Day 1)

Population: FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses.

Day 1 refers to the time an infant's birth.

Outcome measures

Measure	Infants n=33 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Infant Characteristics at Birth: Body Length	51.58 cm Standard Deviation 2.15

SECONDARY outcome

Timeframe: During pregnancy (anytime between 37 to 42 weeks of gestation) and at birth (at Day 1)

Population: Safety analysis set women (SAFW) included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy.

Pregnancy outcomes analysed included live births (term and preterm, presence of congenital anomalies) and elective/therapeutic abortions and stillbirths.

Outcome measures

Measure	Infants n=35 Participants Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth Live Births	100 percentage of pregnancies
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth Congenital Anomalies	8.6 percentage of pregnancies
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth Therapeutic Abortions	0 percentage of pregnancies
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth Stillbirth	0 percentage of pregnancies
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth Preterm	0 percentage of pregnancies

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)

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.

Outcome measures

Outcome data not reported

Adverse Events

Women

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Infants

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Women n=35 participants at risk Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.	Infants n=35 participants at risk Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Cardiac disorders Cardiopulmonary failure	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Hepatobiliary disorders Cholecystitis acute	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Neonatal infection	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Post procedural infection	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Investigations Heart rate decreased	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Reproductive system and breast disorders Uterine inflammation	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.

Other adverse events

Measure	Women n=35 participants at risk Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth.	Infants n=35 participants at risk Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.
Gastrointestinal disorders Constipation	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Gastrointestinal disorders Diarrhoea	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	11.4% 4/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
General disorders Pyrexia	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	8.6% 3/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Immune system disorders Milk allergy	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	8.6% 3/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Bronchitis	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	14.3% 5/35 • Number of events 5 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations COVID-19	17.1% 6/35 • Number of events 7 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	11.4% 4/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Conjunctivitis	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	11.4% 4/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Ear infection	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	14.3% 5/35 • Number of events 5 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Nasopharyngitis	11.4% 4/35 • Number of events 6 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	17.1% 6/35 • Number of events 6 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Sinusitis	5.7% 2/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Upper respiratory tract infection	5.7% 2/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Urinary tract infection	5.7% 2/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Infections and infestations Vulvovaginal mycotic infection	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Injury, poisoning and procedural complications Infusion related reaction	8.6% 3/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Injury, poisoning and procedural complications Perineal injury	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Injury, poisoning and procedural complications Vulvovaginal injury	8.6% 3/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Investigations Blood glucose increased	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Investigations Blood immunoglobulin G decreased	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Metabolism and nutrition disorders Iron deficiency	14.3% 5/35 • Number of events 5 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Nervous system disorders Headache	8.6% 3/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Respiratory, thoracic and mediastinal disorders Cough	11.4% 4/35 • Number of events 5 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	11.4% 4/35 • Number of events 5 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.6% 3/35 • Number of events 3 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.9% 1/35 • Number of events 1 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 4 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/35 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.	5.7% 2/35 • Number of events 2 • Mothers: Up to approximately 79 weeks; Infants: Up to approximately 66 weeks Safety analysis was performed on the safety populations of women (SAFW) and infants (SAFI) separately. The study is still ongoing and data collected up to primary completion date is reported here. Adverse event data will be updated one year after study completion date.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER