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.

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

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 received my last ocrelizumab dose differently from the recommended guidelines.

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

I have a history of weak immune system.

I am not taking medication known to cause birth defects.

Participant Groups

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.

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.