Ocrelizumab Exposure During Pregnancy for Multiple Sclerosis

(MINORE Trial)

No longer recruiting at 15 trial locations

Overseen By Reference Study ID Number: MN42988 https://forpatients.roche.com/

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Hoffmann-La Roche

Must be taking: Ocrelizumab

Must not be taking: Interferons, Glatiramer, Corticosteroids, others

Disqualifiers: Obesity, Immunodeficiency, Malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how ocrelizumab, a medication for multiple sclerosis (MS) or clinically isolated syndrome (CIS), affects pregnancy and the baby. Researchers aim to determine if the drug passes from mother to baby through the placenta and its impact on the baby's immune system. Women who are currently pregnant, have MS or CIS, and took ocrelizumab within six months before pregnancy or during the first trimester are suitable candidates for this trial. As a Phase 4 trial, this research provides insights into how the already FDA-approved and effective treatment benefits more patients, offering valuable information for pregnant women with MS or CIS.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. Specifically, you cannot be on treatments like interferons, glatiramer acetate, pulsed corticosteroids, or other disease-modifying therapies for MS close to the time of your last ocrelizumab dose or before your last menstrual period. Additionally, if you have been on teriflunomide, specific conditions must be met regarding its levels in your body.

What is the safety track record for ocrelizumab?

Research shows that ocrelizumab, a treatment for multiple sclerosis (MS), has been studied in pregnant women with MS. Data from studies involving over 3,000 pregnancies found that ocrelizumab did not increase the risk of problems for the pregnancy or the baby. This suggests that ocrelizumab is generally safe to use during pregnancy. However, the full risk of using ocrelizumab during pregnancy remains not completely understood. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ocrelizumab for multiple sclerosis (MS) because it targets B cells, a type of immune cell involved in the disease's progression. Unlike other treatments like interferons or glatiramer acetate, which generally modulate the immune system more broadly, ocrelizumab selectively depletes B cells, potentially offering a more focused approach. This specificity could lead to better control over MS symptoms and progression with fewer side effects. Additionally, ocrelizumab is administered via infusion only twice a year, which is less frequent than many existing therapies, offering greater convenience for patients.

What evidence suggests that ocrelizumab might be an effective treatment for multiple sclerosis?

Research has shown that ocrelizumab helps manage multiple sclerosis (MS). Studies found that it reduces the risk of worsening disability by 30% for those who use it. In this trial, researchers are observing pregnant women with CIS or MS who received ocrelizumab up to 6 months before the last menstrual period (LMP) or during the first trimester of pregnancy. Importantly, taking ocrelizumab during pregnancy did not increase the risk of problems for babies, as infants born to these women are also being monitored. These findings suggest that ocrelizumab can be a safe and effective choice for managing MS. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for pregnant women diagnosed with MS or CIS, within 30 weeks of gestation, who have had ocrelizumab treatment up to 6 months before pregnancy or during the first trimester. Women must not have a high-risk pregnancy, other severe diseases, history of drug abuse, or recent use of certain MS treatments.

Inclusion Criteria

Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period

I am pregnant with one baby and not more than 30 weeks along.

I have been diagnosed with multiple sclerosis or clinically isolated syndrome.

Exclusion Criteria

I do not have any severe illnesses that would stop me from joining the study.

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

I haven't taken MS medications within their half-life before my last ocrelizumab dose or my last menstrual period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Evaluate potential placental transfer of ocrelizumab and corresponding pharmacodynamic effects in infants

Up to gestational week 13

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview

The study tests if ocrelizumab can transfer from mother to baby during pregnancy and how it affects B cell levels in infants. It's for women who took the drug near conception and monitors their babies' immune cells after birth.

How Is the Trial Designed?

Group I: Pregnant Women with CIS or MS Experimental Treatment 1 Intervention

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.

Group II: Infants Active Control 1 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 Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Illingworth

Collaborator

Trials

2

Recruited

60+

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+

Illingworth Research Group

Collaborator

Trials

2

Recruited

60+

Published Research Related to This Trial

In a review of 78 studies involving 4498 patients, 61.3% of those treated with ocrelizumab experienced adverse events, with the most common being infections (39.2%) and infusion-related reactions (26.2%).

Ocrelizumab was associated with a higher risk of infections compared to beta-interferon, particularly herpes-related and respiratory infections, while the risk of serious adverse events was similar between ocrelizumab and comparator groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. Ng, HS., Rosenbult, CL., Tremlett, H.[2022]

Ocrelizumab is the first drug approved by the European Medicines Agency for treating both early primary progressive multiple sclerosis and relapsing forms of multiple sclerosis, highlighting its significance in MS treatment.

The review discusses the safety and effectiveness of ocrelizumab, indicating it has undergone rigorous evaluation to support its use in adults with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis. [2018]

Ocrelizumab is a humanized anti-CD20 monoclonal antibody specifically designed to deplete B cells, which are implicated in the development of multiple sclerosis (MS).

Approved in March 2017 in the USA for treating both relapsing and primary progressive forms of MS, ocrelizumab represents a significant advancement in MS therapy, with its approval in the EU currently pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval. Frampton, JE.[2022]

Citations

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gene.com

gene.com/media/press-releases/15078/2025-09-23/genentech-presents-new-data-for-ocrevus-

Genentech: Press Releases | Tuesday, Sep 23, 2025

Ocrevus shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression (cCDP) in adults with advanced ...

2.

ocrevus-hcp.com

ocrevus-hcp.com/ocrevus/pregnancy-lactation.html

Pregnancy and Lactation Data | OCREVUS® (ocrelizumab)

In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS- ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8905230/

Pregnancy outcome following exposure to ocrelizumab in ...

Our data suggests that patients with MS who had been treated with ocrelizumab before pregnancy experienced a stable MS disease course throughout ...

4.

genentech-medinfo.com

genentech-medinfo.com/our-products/neuroscience/ocrevus/pregnancy-and-lactation.html

Pregnancy & Lactation in MS | Ocrevus® (ocrelizumab)

The developmental risk associated with the use of Ocrevus in pregnant women has not been determined. Women of childbearing potential should use effective ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39689270/

Pregnancy and Infant Outcomes in Women With Multiple ...

In utero exposure to ocrelizumab was not associated with an increased risk of adverse pregnancy or infant outcomes.

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2024/761371s000lbl.pdf

Ocrevus Zunovo - accessdata.fda.gov

The safety of ocrelizumab has been evaluated in active-controlled clinical trials of ocrelizumab administered intravenously in patients with relapsing forms of ...