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Monoclonal Antibodies
Ocrelizumab for Multiple Sclerosis in Lactating Women (SOPRANINO Trial)
Phase 4
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Woman is between 18 and 40 years of age at screening
Infant is between 2-24 weeks of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after the first or second dose of measles, mumps, and rubella (mmr) vaccine, or at month 13, in case mmr vaccine is not planned to be administered
Awards & highlights
SOPRANINO Trial Summary
This trial will study how ocrelizumab affects breastmilk and infants.
Who is the study for?
This trial is for lactating women aged 18-40 with CIS or MS who are willing to breastfeed and provide milk samples. Their infants must be between 2-24 weeks old. Women must have had their last ocrelizumab dose more than 3 months before pregnancy, agree to use contraception, and not have a history of severe immune issues, active infections, malignancies, or certain breast surgeries.Check my eligibility
What is being tested?
The study tests how much of the MS drug Ocrelizumab gets into breastmilk and its effects on B cell levels in infants. It involves mothers with CIS or MS receiving Ocrelizumab post-partum while breastfeeding and providing milk samples for analysis.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions like itching or rash, infections due to weakened immunity, potential liver problems indicated by yellowing skin/eyes (jaundice), tiredness (fatigue), and possible respiratory symptoms such as coughing.
SOPRANINO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 18 and 40.
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My baby is between 2 to 24 weeks old.
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I am a woman diagnosed with multiple sclerosis or clinically isolated syndrome.
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I am willing to provide samples of my breastmilk.
SOPRANINO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after the first or second dose of measles, mumps, and rubella (mmr) vaccine, or at month 13, in case mmr vaccine is not planned to be administered
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after the first or second dose of measles, mumps, and rubella (mmr) vaccine, or at month 13, in case mmr vaccine is not planned to be administered
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Estimated average oral daily infant dosage (ADID)
Proportion of infants with B cell levels (CD19+ cells) below the lower limit of normal (LLN)
Secondary outcome measures
Area under the milk concentration-time curve (AUC) of ocrelizumab in mature breastmilk
Average ocrelizumab milk concentration
B cell levels (CD19+ cells) in the infant
+16 moreSOPRANINO Trial Design
1Treatment groups
Experimental Treatment
Group I: Women with CIS or MSExperimental Treatment1 Intervention
Lactating women with CIS or MS (in line with the locally approved indications) who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum. Women resuming treatment with ocrelizumab post-partum will be included only if the last exposure to ocrelizumab occurred more than 3 months before the last menstrual period to exclude any interference between fetal exposure and exposure via lactation.
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?
Laboratory Corporation of AmericaIndustry Sponsor
28 Previous Clinical Trials
9,967 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
44 Patients Enrolled for Multiple Sclerosis
PPDIndustry Sponsor
161 Previous Clinical Trials
36,969 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
371 Patients Enrolled for Multiple Sclerosis
Illingworth Research GroupUNKNOWN
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
44 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to ocrelizumab or any of its ingredients.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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Women with CIS or MS
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- 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.
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