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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 willing to breastfeed for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation)
Woman is between 18 and 40 years of age at screening
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 below
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I am willing to breastfeed for at least 60 days after my first ocrelizumab infusion post-partum.
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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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My infant is between 2 to 24 weeks old when I start my ocrelizumab treatment.
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I took ocrelizumab more than 3 months before my last period at the approved dose.
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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 breastmilk samples.
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I am willing to provide samples of my breastmilk.

SOPRANINO Trial 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

SOPRANINO 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?

IllingworthUNKNOWN
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
44 Patients Enrolled for Multiple Sclerosis
Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,112 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
25,009 Patients Enrolled for Multiple Sclerosis
PPDIndustry Sponsor
158 Previous Clinical Trials
36,763 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
433 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04998851 — Phase 4
Multiple Sclerosis Research Study Groups: Women with CIS or MS
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04998851 — Phase 4
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04998851 — Phase 4

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Mar 2025