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Ocrelizumab Exposure During Pregnancy for Multiple Sclerosis (MINORE Trial)

Phase 4
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 hour after delivery
Awards & highlights

MINORE Trial Summary

This trial will study the transfer of the drug ocrelizumab to the fetus through the placenta in pregnant women with clinically isolated syndrome or multiple sclerosis, and the effects of the drug on infants.

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.Check my eligibility
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.See study design
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.

MINORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant with one baby and not more than 30 weeks along.
Select...
I have been diagnosed with multiple sclerosis or clinically isolated syndrome.

MINORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 hour after delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 hour after delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
B-Lymphocytes
Secondary outcome measures
B cell levels (CD19+ cells) in the infant
Infant characteristics at birth (body length)
Infant characteristics at birth (body weight)
+17 more

MINORE 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 3
~5730

Find a Location

Who is running the clinical trial?

IllingworthUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
20 Patients Enrolled for Multiple Sclerosis
Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,088 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,985 Patients Enrolled for Multiple Sclerosis
PPDIndustry Sponsor
158 Previous Clinical Trials
36,739 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
409 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab Clinical Trial Eligibility Overview. Trial Name: NCT04998812 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the criteria for participating in this research project?

"This medical study is seeking 44 persons of legal age, between 18 and 40 years old, who have been formally diagnosed with multiple sclerosis or Clinically Isolated Syndrome. The inclusion criteria also requires that they be within the gestational period ≤30 Weeks at time of enrollment; both first and second obstetric ultrasounds must have been conducted prior to enrolment, as well as a documented last exposure to ocrelizumab up to 6 months before their Last Menstrual Period (LMP) or during the first trimester of pregnancy."

Answered by AI

Does the criterion for enrollment in this medical experiment extend beyond 45 years of age?

"The requisite age range to be admitted into this medical study is 18-40 years old."

Answered by AI

Has Ocrelizumab obtained the sanction of regulatory authorities?

"Data from Phase 4 clinical trials suggests a favorable safety profile for Ocrelizumab, leading to it receiving the highest rating of 3."

Answered by AI

What is the geographical distribution of sites for this trial?

"This clinical trial is being administered at the Hospital of the University of Pennsylvania, Icahn School of Medicine at Mount Sinai and University of Alberta Hospital in addition to 8 other centres."

Answered by AI

Has a similar trial been conducted previously?

"Currently, 29 live trials for Ocrelizumab are underway across 321 cities and 60 countries. The inaugural clinical trial of the drug was conducted in 2008 by Genentech, Inc., which evaluated 220 participants through Phase 2 approval stages. In the years since then 10 additional studies have been carried out."

Answered by AI

Are there any additional investigations involving Ocrelizumab?

"Since its initial trial at CHU De Nimes, Hopital Caremeau; Service de Neurologie Du Prof. Pierre Labauge back in 2008, there have been 10 completed clinical trials on ocrelizumab. Currently, 29 new studies are being conducted across different locations with a large concentration of them based around Philadelphia, Pennsylvania."

Answered by AI

What is the highest patient enrollment cap for this medical research?

"The sponsor, Laboratory Corporation of America, will launch the trial in a range of centres with 44 participants who meet the criteria. Specifically, they are recruiting at Hospital of the University of Pennsylvania (Philadelphia) and Icahn School Medicine at Mount Sinai (New york)."

Answered by AI

Is the enrollment of participants still open for this medical experiment?

"According to the clinicaltrials.gov database, this research is still looking for participants. It was initially publicized on April 13th 2022 and it was recently updated in November 14th 2022."

Answered by AI
~2 spots leftby May 2024