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Ocrelizumab Exposure During Pregnancy for Multiple Sclerosis (MINORE 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

Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment

Diagnosis of MS or CIS (in line with the locally approved indications)

Must not have

Received the last dose of ocrelizumab at a different posology other than per the local prescribing information

Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this study focuses on infant B cell levels rather than side effects directly, ocrelizumab may cause infusion reactions, infections due to low B cell counts (immunosuppression), and potential unknown risks to the fetus.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

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

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I received my last ocrelizumab dose differently from the recommended guidelines.

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I am a woman currently being treated or monitored for cancer recurrence.

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I have a history of weak immune system.

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I am not taking medication known to cause birth defects.

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

Drug Has Already Been Approved

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

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Women with CIS or MSExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~10080

0 / 6Eligibility criteria met