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Ocrelizumab for Multiple Sclerosis in Lactating Women (SOPRANINO Trial)
SOPRANINO Trial Summary
This trial will study how ocrelizumab affects breastmilk and infants.
SOPRANINO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOPRANINO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SOPRANINO Trial Design
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Who is running the clinical trial?
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- You are allergic to ocrelizumab or any of its ingredients.I am willing to breastfeed for at least 60 days after my first ocrelizumab infusion post-partum.My baby was older than 24 weeks when I first received ocrelizumab.You have a condition that could make breastfeeding difficult or affect how your body absorbs milk.I haven't taken experimental drugs within the last 6 months.I am a woman aged between 18 and 40.You have tested positive for hepatitis B during the screening tests.You have experienced at least one unexplained event that caused you to stop breathing, turn blue, or become very pale.My baby is between 2 to 24 weeks old.I do not have any current infections.You have a history of drinking alcohol or using drugs in a harmful way.I have taken medication for MS or CIS during pregnancy or just after birth, but not interferon-beta, glatiramer acetate, or pulsed corticosteroids.I do not have any active infections or my infection has been treated and resolved.I am currently being treated or monitored for cancer recurrence.I am not taking medications that can harm a nursing baby through breastmilk.A woman has given birth to a healthy baby at full term (37 weeks or more).My infant is between 2 to 24 weeks old when I start my ocrelizumab treatment.I took ocrelizumab more than 3 months before my last period at the approved dose.I am a woman diagnosed with multiple sclerosis or clinically isolated syndrome.I am willing to provide breastmilk samples.I took ocrelizumab less than 3 months before my last menstrual period or during pregnancy.A woman has given birth to a full-term single baby (at least 37 weeks of pregnancy).I am willing to provide samples of my breastmilk.I plan to breastfeed for at least 60 days after my first post-partum ocrelizumab infusion.I have had breast surgery, including implants, augmentation, reduction, or mastectomy.I have a history of weak immune system.
- Group 1: Women with CIS or MS
- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the total recruitment threshold for this clinical trial?
"The sponsor, PPD, is tasked with finding 20 qualified patients to run this medical trial. They will be recruiting from the Hospital of University Pennsylvania in Philadelphia and the University Of Colorado in Aurora."
Are participants aged 30 or above eligible for this research project?
"According to the rules set forth by this trial, only individuals between 18 and 40 years old are eligible for recruitment."
What other research has been conducted relating to Ocrelizumab?
"Ocrelizumab, which was first trialled in 2008 at CHU De Nimes and Hopital Caremeau, has completed 10 clinical experiments. Currently there are 29 ongoing studies, many of them taking place around Philadelphia, Pennsylvania."
How many research institutions are currently conducting this trial?
"This clinical trial is being conducted in 8 different sites, some of which include the Hospital of the University of Pennsylvania in Philadelphia, University Of Colorado in Aurora and Northwestern Memorial Hospital in Chicago."
Is it feasible for me to join this clinical trial?
"This MS clinical trial is looking for 20 female participants aged between 18 and 40 who have recently delivered a term singleton infant. These women must be willing to provide breastmilk samples, commit to breastfeeding their baby for at least two months after the first post-partum ocrelizumab infusion (which must occur independently from study participation), and have an infant that is aged 2-24 weeks old."
Is this research endeavor actively seeking participants?
"Affirmative. The information present on clinicaltrials.gov attests that this trial is ongoing and recruiting patients, with the original post being published as of September 16th 2021. 20 participants need to be recruited from 8 different healthcare facilities prior to its completion date at November 16th 2022."
Is Ocrelizumab considered a secure remedy for people?
"Due to its Phase 4 status, Ocrelizumab is already approved for use, and thus receives a safety score of 3."
Is this investigation a pioneering endeavor?
"Currently, 29 active research initiatives concerning Ocrelizumab are running in 321 cities and 60 different nations. A trial sponsored by Genentech, Inc., was the first to put Ocrelizumab under clinical scrutiny back in 2008, involving 220 participants who successfully completed Phase 2 drug approval. Since then, 10 additional studies have reached their conclusion."
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