Ocrelizumab Exposure During Pregnancy for Multiple Sclerosis
(MINORE Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

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.

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.

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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.

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Treatment Details

Interventions

Ocrelizumab (Monoclonal Antibodies)

Trial OverviewThe 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

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.