Multiple SclerosisPhase 4MINORENCT04998812
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Hoffmann-La Roche at 11 sites in 5 countries.
Trial summary
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP)… 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
- 70 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 13 Apr 2022to 14 Jul 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
- Diagnosis of MS or CIS (in line with the locally approved indications)
- Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment
- Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
- Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy
Who cannot join
- Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
- Gestational age at enrolment >30 weeks
- Non-singleton pregnancy
- Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
- Lack of access to ultrasound pre-natal care as part of standard clinical practice
- Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
Show all 19Show fewer
- Pre-pregnancy body mass index >35 kg/m2
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
- Significant and uncontrolled disease that may preclude a woman from participating in the study
- Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies
- Prior or current history of alcohol or drug abuse, or current use of tobacco
- Positive screening tests for hepatitis B
- Treatment with drugs known to have teratogenic effects
- Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
- Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
- Treatment with natalizumab within 12 weeks prior to the LMP
- Treatment with teriflunomide within the last two years, unless measured plasma concentrations are <0.02 mg/L. If levels are >0.02 mg/L or not known, an accelerated elimination procedure is required
- Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States4 sites
University Of Colorado
Aurora, Colorado, 80045
The Ken and Ruth Davee department of Neurology
Chicago, Illinois, 60611-4296
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94158
France2 sites
Hopital Pierre Wertheimer - Hopital Neurologique
Bron, 69003
Hôpital de la Pitié Salpétrière
Paris, 75013
Germany2 sites
St. Josef Hospital GmbH
Bochum, 44791
MultipEL Studies - Institut für klinische Studien
Hamburg, 22179
Switzerland2 sites
Universitätsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
About this study
Official title: A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Being tested
- Ocrelizumab
- Keywords
- ocrelizumab, OCREVUS, placental transfer, pregnancy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Post-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women with CIS or MS | Experimental | Pregnant women with CIS or MS (in line with the locally approved indications) receiving commercial ocrelizumab up to 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. Receives: Drug: Ocrelizumab |
| Infants | No intervention | 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. |
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)
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.
Measured: At Week 6 of infant's life
Secondary outcomes (25)
Absolute CD19+ B Cell Count in the Infant Potentially Exposed to Ocrelizumab During Pregnancy
Measured: At Week 6 of infant's life
Percentage of CD19+ B Cell in the Infant Potentially Exposed to Ocrelizumab During Pregnancy
Measured: At Week 6 of infant's life
Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth
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.
Measured: Within 1 hour after delivery (at birth, Day 1)
Serum Concentration of Ocrelizumab in the Infant at Week 6 of Life
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.
Measured: At Week 6 of infant's life
Serum Concentration of Ocrelizumab in the Mother
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.
Measured: Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth, Day 1)
Percentage of Infants With Adverse Events
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. Percentages have been rounded off.
Measured: Up to approximately 71 weeks
Percentage of Mothers With Adverse Events
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. Percentages have been rounded off.
Measured: Up to approximately 87.6 weeks
Infant Characteristics at Birth: Body Weight
Day 1 refers to the time an infant's birth.
Measured: At birth (Day 1)
Infant Characteristics at Birth: Head Circumference
Day 1 refers to the time an infant's birth.
Measured: At birth (Day 1)
Infant Characteristics at Birth: Body Length
Day 1 refers to the time an infant's birth.
Measured: At birth (Day 1)
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Pregnancy outcomes analysed included live births (term and preterm, presence of congenital anomalies) and elective/therapeutic abortions and stillbirths.
Measured: During pregnancy (anytime between 37 to 42 weeks of gestation) and at birth (at Day 1)
Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to MMR Vaccination
The immune response to MMR vaccination 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 vaccination 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 vaccination 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) are 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 U/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL. Percentages have been rounded off.
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) Vaccination
The immune response to DTP vaccination 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 Vaccination
The immune response to DTP vaccination 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 Vaccination
The immune response to DTP vaccination 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 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 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 COI. 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 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 Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccination
The immune response to Hib vaccination 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 Vaccination
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.
Measured: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Antibody Immune Responses to Hepatitis B Virus (HBV) Vaccination
The immune response to HBV vaccination 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.
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 Vaccination
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 Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination
The immune response to PCV-13 vaccination 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 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 PCV-13 vaccine are as follows: 13 Valent anti-pneumococcal antibody panel: ≥ 0.35 µg/ml. Percentages have been rounded off.
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 start13 Apr 2022
- Primary completion8 Apr 2024
- Study completion14 Jul 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
- Model description
- 35 pregnant women with singleton pregnancy were enrolled in the study (70 participants in total, including the infants).
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT04998812
- Sponsor's protocol ID
- MN42988
- Other IDs
- 2021-000062-14, 2024-510974-25-00
- Acronym
- MINORE
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2021
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 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 Potentially Exposed To Ocrelizumab During Pregnancy
- ClinicalTrials.gov ID
- NCT04998812
- Acronym / sponsor ID
- MINORE / MN42988
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- ocrelizumab, OCREVUS, placental transfer, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Laboratory Corporation of America, Illingworth Research Group
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Posted 22 May 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 potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 35 pregnant women with singleton pregnancy were enrolled in the study (70 participants in total, including the infants).
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women with CIS or MS | Experimental | Drug: OcrelizumabPregnant women with CIS or MS (in line with the locally approved indications) receiving commercial ocrelizumab up to 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. |
| Infants | No intervention | –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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of MS or CIS (in line with the locally approved indications)
- Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment
- Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
- Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy
Key exclusion criteria (19 listed)
- Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
- Gestational age at enrolment >30 weeks
- Non-singleton pregnancy
- Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
- Lack of access to ultrasound pre-natal care as part of standard clinical practice
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 |
|---|---|---|
| OcrelizumabPost-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling. | Drug | Pregnant 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)
Time frame: At Week 6 of infant's life
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.
25 secondary outcomes
Absolute CD19+ B Cell Count in the Infant Potentially Exposed to Ocrelizumab During Pregnancy
Time frame: At Week 6 of infant's life
Percentage of CD19+ B Cell in the Infant Potentially Exposed to Ocrelizumab During Pregnancy
Time frame: At Week 6 of infant's life
Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth
Time frame: Within 1 hour after delivery (at birth, Day 1)
Serum Concentration of Ocrelizumab in the Infant at Week 6 of Life
Time frame: At Week 6 of infant's life
Serum Concentration of Ocrelizumab in the Mother
Time frame: Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth, Day 1)
Percentage of Infants With Adverse Events
Time frame: Up to approximately 71 weeks
Percentage of Mothers With Adverse Events
Time frame: Up to approximately 87.6 weeks
Infant Characteristics at Birth: Body Weight
Time frame: At birth (Day 1)
Infant Characteristics at Birth: Head Circumference
Time frame: At birth (Day 1)
Infant Characteristics at Birth: Body Length
Time frame: At birth (Day 1)
Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth
Time frame: During pregnancy (anytime between 37 to 42 weeks of gestation) and at birth (at Day 1)
Mean Titers of Measles, Immunoglobin G (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 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) Vaccination
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 Vaccination
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 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 DTP Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) 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 Hib Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Antibody Immune Responses to Hepatitis B Virus (HBV) 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 HBV Vaccination
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) 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 PCV-13 Vaccination
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 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
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
11 sites in 5 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 11 sites in 5 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 4 inclusion and 19 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, Germany, Switzerland, Spain. 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 22 May 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) (time frame: At Week 6 of infant's life). 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 15 Apr 2026.