Multiple SclerosisPhase 4SOPRANINONCT04998851
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Hoffmann-La Roche at 8 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 16 Sep 2021to 13 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman is between 18 and 40 years of age at screening
- Woman is willing to breastfeed for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation)
- Woman is willing to provide breastmilk samples
- Woman has a diagnosis of MS or CIS (in line with the locally approved indications)
- Woman has delivered a healthy term singleton infant (≥37 weeks gestation)
- Infant is between 2-24 weeks of age at the time of the mother's first post-partum dose of ocrelizumab
- For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure to ocrelizumab occurred more than 3 months before the last menstrual period (LMP) and was given at the approved dose of 2 x 300 mg or 1 x 600 mg
- Woman agrees to use acceptable contraceptive methods during the study
Who cannot join
- Hypersensitivity to ocrelizumab or to any of its excipients
- Received last dose of ocrelizumab <3 months before the LMP or during pregnancy
- Active infections (may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved)
- Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
- Known active malignancies, or being actively monitored for recurrence of malignancy
- History of breast implants, breast augmentation, breast reduction surgery or mastectomy
Show all 16Show fewer
- Prior or current history of chronic alcohol abuse or drug abuse
- Positive screening tests for hepatitis B
- Treatment with a DMT for CIS or MS during pregnancy and/or first weeks post-partum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids
- Treatment with drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant
- Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the LMP
- >24 weeks of life at the time of the mother's first dose of ocrelizumab
- Any abnormality that may interfere with breastfeeding or milk absorption
- Active infection (may be included once the infection resolves)
- Infant has any other medical condition or abnormality that, in the opinion of the investigator, could compromise the infant's ability to participate in this study, including interference with the interpretation of study results
- At least one documented brief resolved unexplained event (BRUE), as defined by the 2016 Guidelines of the American Academy of Pediatrics
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
University Of Colorado
Aurora, Colorado, 80045
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Northwestern Memorial Hospital
Chicago, Illinois, 60611-2987
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso, Michigan, 48867
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
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.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Being tested
- Ocrelizumab
- Keywords
- ocrelizumab, OCREVUS, breastmilk transfer, breast milk transfer, lactation
- Medical subject headings
- Multiple Sclerosis, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Women with CIS or MS | Experimental | Lactating women with CIS or MS (in line with the locally approved indications) who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum. Women resuming treatment with ocrelizumab post-partum will be included only if the last exposure to ocrelizumab occurred more than 3 months before the last menstrual period to exclude any interference between fetal exposure and exposure via lactation. Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: At Day 30
Estimated Average Oral Daily Infant Dosage (ADID)
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.
Measured: Up to Day 60
Secondary outcomes (25)
Absolute CD19+ B Cell Count in the Infant
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).
Measured: At Day 30
Percentage of CD19+ B Cell in the Infant
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).
Measured: At Day 30
Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk
Measured: 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
Average Concentration of Ocrelizumab in Breastmilk (Cmean)
Measured: 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
Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk
Measured: 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
Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk
Measured: 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
Estimated Maximum Oral Daily Infant Dosage (MDID)
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.
Measured: Up to Day 60
Average Relative Infant Dose (RID)
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.
Measured: Up to Day 60
Serum Concentration of Ocrelizumab in the Infant at Day 30
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.
Measured: At Day 30
Percentage of Mothers With Adverse Events (AEs)
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.
Measured: Up to approximately 73.3 weeks after first ocrelizumab dose
Percentage of Infants With AEs
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.
Measured: Up to approximately 73.3 weeks after first ocrelizumab dose administered to mother
Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination
The immune response to MMR vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. mIU/mL=milli-international units per milliliter.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination
The immune response to MMR vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. RU/mL=relative units per milliliter.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination
The immune response to MMR vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. IU/mL=international units per milliliter.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for MMR vaccine are as follows: Anti-Measles Vir IgG(-70)CL: ≥ 120 mIU/mL; Anti-MumpsAT Vir iGG(-70)CL: ≥ 17 RU/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine
The immune response to DTP vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccine
The immune response to DTP vaccine was 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 was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows:
- COI < 0.95: Negative
- COI 0.95-1.04: Equivocal
- COI > 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (>1.04).
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccine
The immune response to DTP vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to DTP Vaccine
The immune response to DTP vaccine was 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 was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows:
- COI < 0.95: Negative
- COI 0.95-1.04: Equivocal
- COI > 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (>1.04).
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine
The immune response to Hib vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to Hib Vaccine
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine
The immune response to HBV vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to HBV Vaccine
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for HBV vaccine are as follows: Anti-HBs: ≥ 10 mIU/mL.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
The immune response to PCV-13 vaccine was 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 was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to PCV-13
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was 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.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start16 Sep 2021
- Primary completion29 Mar 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Laboratory Corporation of America, Illingworth Research Group
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998851
- Sponsor's protocol ID
- MN42989
- Other IDs
- 2021-000063-79
- Acronym
- SOPRANINO
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2021
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
- ClinicalTrials.gov ID
- NCT04998851
- Acronym / sponsor ID
- SOPRANINO / MN42989
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- ocrelizumab, OCREVUS, breastmilk transfer, breast milk transfer, lactation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Laboratory Corporation of America, Illingworth Research Group
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with CIS or MS | Experimental | Drug: OcrelizumabLactating women with CIS or MS (in line with the locally approved indications) who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum. Women resuming treatment with ocrelizumab post-partum will be included only if the last exposure to ocrelizumab occurred more than 3 months before the last menstrual period to exclude any interference between fetal exposure and exposure via lactation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Woman is between 18 and 40 years of age at screening
- Woman is willing to breastfeed for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation)
- Woman is willing to provide breastmilk samples
- Woman has a diagnosis of MS or CIS (in line with the locally approved indications)
- Woman has delivered a healthy term singleton infant (≥37 weeks gestation)
Key exclusion criteria (16 listed)
- Hypersensitivity to ocrelizumab or to any of its excipients
- Received last dose of ocrelizumab <3 months before the LMP or during pregnancy
- Active infections (may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved)
- Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
- Known active malignancies, or being actively monitored for recurrence of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabWomen will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information. | Drug | Women with CIS or MS |
Primary outcome
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
Time frame: At Day 30
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.
Estimated Average Oral Daily Infant Dosage (ADID)
Time frame: Up to Day 60
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.
25 secondary outcomes
Absolute CD19+ B Cell Count in the Infant
Time frame: At Day 30
Percentage of CD19+ B Cell in the Infant
Time frame: At Day 30
Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk
Time frame: 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
Average Concentration of Ocrelizumab in Breastmilk (Cmean)
Time frame: 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
Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk
Time frame: 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
Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk
Time frame: 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
Estimated Maximum Oral Daily Infant Dosage (MDID)
Time frame: Up to Day 60
Average Relative Infant Dose (RID)
Time frame: Up to Day 60
Serum Concentration of Ocrelizumab in the Infant at Day 30
Time frame: At Day 30
Percentage of Mothers With Adverse Events (AEs)
Time frame: Up to approximately 73.3 weeks after first ocrelizumab dose
Percentage of Infants With AEs
Time frame: Up to approximately 73.3 weeks after first ocrelizumab dose administered to mother
Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to DTP Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to Hib Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to HBV Vaccine
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Percentage of Infants With Positive Humoral Response to PCV-13
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Hoffmann-La Roche at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.