Ocrelizumab Exposure During Pregnancy for Multiple Sclerosis

(MINORE Trial)

Recruiting at 14 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

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will study how a medication for multiple sclerosis transfers from pregnant women to their babies. The focus is on women who took the medication around the time of pregnancy. Researchers will look at how this affects the baby's immune cells and overall health.

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 data supports the effectiveness of the drug Ocrelizumab for treating multiple sclerosis?

Ocrelizumab is a drug that targets B cells, which are involved in the development of multiple sclerosis (MS). It has been approved for treating relapsing and primary progressive forms of MS, showing effectiveness in managing the disease without causing rebound relapses after stopping the treatment. ^{1 2 3 4 5}

Is ocrelizumab safe to use during pregnancy for multiple sclerosis?

There is limited safety data on using ocrelizumab during pregnancy, but some reports suggest no harmful effects on infants when exposed in the second trimester, with normal infant development observed. ^{1 4 5 6 7}

How is the drug ocrelizumab unique for treating multiple sclerosis during pregnancy?

Ocrelizumab is unique because it is a monoclonal antibody that targets CD20-expressing B cells, which are involved in the development of multiple sclerosis. Unlike other treatments, it is highly effective for relapsing-remitting MS and does not cause rebound relapses after discontinuation, although its safety during pregnancy is still being studied. ^{1 3 4 5 8}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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.

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

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Ocrelizumab exposure in the second trimester of pregnancy without neonatal B-cell depletion. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: A cohort study from Germany. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pregnancy outcomes of women with multiple sclerosis treated with ocrelizumab in Canada: A descriptive analysis of real-world data. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pregnancy outcome following exposure to ocrelizumab in multiple sclerosis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Ocrelizumab during pregnancy and lactation: Rationale and design of the MINORE and SOPRANINO studies in women with MS and their infants. [2022]