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Ocrelizumab Exposure During Pregnancy for Multiple Sclerosis (MINORE Trial)
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.
MINORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMINORE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MINORE Trial Design
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Who is running the clinical trial?
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- I do not have any severe illnesses that would stop me from joining the study.I haven't taken MS medications within their half-life before my last ocrelizumab dose or my last menstrual period.I plan to use specific medications as a bridge therapy after my last ocrelizumab dose and during pregnancy.I am pregnant with one baby and not more than 30 weeks along.I have been diagnosed with multiple sclerosis or clinically isolated syndrome.I received my last ocrelizumab dose differently from the recommended guidelines.I last used ocrelizumab up to 6 months before my last menstrual period or during the first trimester.I need long-term steroids or immunosuppressants for another condition.I last used ocrelizumab more than 6 months before my last menstrual period or after my first trimester.I have not taken natalizumab in the last 12 weeks.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.I haven't taken teriflunomide in the last 2 years, or my levels are low enough.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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)."
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."
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