What side effects are associated with this type of intervention?

Ocrelizumab, a B cell depleting therapy, is used to treat Multiple Sclerosis (MS) and has several known side effects. Common side effects include infusion-related reactions, which can manifest as rash, itching, and respiratory issues. There is also an increased risk of infections, including respiratory tract infections and herpes infections. Other potential side effects include a higher risk of malignancies, particularly breast cancer, and a possible increase in liver enzyme levels. Patients should be monitored for these side effects during treatment.

What prior FDA approvals exist?

Ocrelizumab (Ocrevus) is an FDA-approved treatment for Multiple Sclerosis (MS) that works by depleting B cells. Another similar B cell-depleting therapy is Rituximab, although it is not specifically approved for MS, it is used off-label. Other FDA-approved treatments for MS include Alemtuzumab (Lemtrada), which targets CD52 on immune cells, and various disease-modifying therapies like Dimethyl fumarate (Tecfidera) and Glatiramer acetate (Copaxone), which modulate the immune response rather than depleting B cells.

What other types of research exist?

Promising novel alternatives to Ocrelizumab for Multiple Sclerosis patients include: 1) Autologous Hematopoietic Stem Cell Transplantation (AHSCT), which has shown long-term benefits in treatment-refractory MS. 2) Ublituximab, a glycoengineered anti-CD20 monoclonal antibody, which has demonstrated positive results in clinical trials. 3) BTK inhibitors like Evobrutinib, which target B-cell signaling pathways and have shown promise in reducing MS disease activity.

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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis in Lactating Women (SOPRANINO Trial)

Phase 4

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Woman is between 18 and 40 years of age at screening

Infant is between 2-24 weeks of life

Must not have

Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the LMP

Known active malignancies, or being actively monitored for recurrence of malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial studies how a medication for multiple sclerosis affects breastmilk in women with MS or CIS. It aims to see how much of the drug gets into the breastmilk and its impact on breastfeeding infants.

Who is the study for?

This trial is for lactating women aged 18-40 with CIS or MS who are willing to breastfeed and provide milk samples. Their infants must be between 2-24 weeks old. Women must have had their last ocrelizumab dose more than 3 months before pregnancy, agree to use contraception, and not have a history of severe immune issues, active infections, malignancies, or certain breast surgeries.

What is being tested?

The study tests how much of the MS drug Ocrelizumab gets into breastmilk and its effects on B cell levels in infants. It involves mothers with CIS or MS receiving Ocrelizumab post-partum while breastfeeding and providing milk samples for analysis.

What are the potential side effects?

Ocrelizumab may cause infusion reactions like itching or rash, infections due to weakened immunity, potential liver problems indicated by yellowing skin/eyes (jaundice), tiredness (fatigue), and possible respiratory symptoms such as coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 40.

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My baby is between 2 to 24 weeks old.

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I am a woman diagnosed with multiple sclerosis or clinically isolated syndrome.

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I am willing to provide samples of my breastmilk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken experimental drugs within the last 6 months.

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I am currently being treated or monitored for cancer recurrence.

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I am not taking medications that can harm a nursing baby through breastmilk.

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I took ocrelizumab less than 3 months before my last menstrual period or during pregnancy.

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I have had breast surgery, including implants, augmentation, reduction, or mastectomy.

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I have a history of weak immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Women with CIS or MSExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~8600

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ocrelizumab, a monoclonal antibody, works by depleting B cells, which are a type of white blood cell involved in the immune response that attacks the myelin sheath in MS patients. By targeting CD20-positive B cells, Ocrelizumab reduces inflammation and slows disease progression. Other common treatments include interferon beta, which modulates the immune response to reduce inflammation, and glatiramer acetate, which mimics myelin basic protein to divert the immune attack away from the myelin sheath. These treatments are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow the progression of the disease, thereby improving quality of life.