Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab (SOPRANINO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04998851
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
PPD
LabCorp
Illingworth
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Clinically Isolated Syndrome Drug: Ocrelizumab Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
Estimated Study Start Date : September 15, 2021
Estimated Primary Completion Date : October 22, 2022
Estimated Study Completion Date : November 8, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Women with CIS or MS
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.
Drug: Ocrelizumab
Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.




Primary Outcome Measures :
  1. Proportion of infants with B cell levels (CD19+ cells) below the lower limit of normal (LLN) [ Time Frame: 30 days after the mother's first post-partum ocrelizumab infusion ]
  2. Estimated average oral daily infant dosage (ADID) [ Time Frame: Over 60 days after the mother's first post-partum ocrelizumab infusion ]

Secondary Outcome Measures :
  1. B cell levels (CD19+ cells) in the infant [ Time Frame: 30 days after the mother's first post-partum ocrelizumab infusion ]
  2. Area under the milk concentration-time curve (AUC) of ocrelizumab in mature breastmilk [ Time Frame: Over 60 days after the mother's first post-partum ocrelizumab infusion ]
  3. Average ocrelizumab milk concentration [ Time Frame: Over 60 days after the mother's first post-partum ocrelizumab infusion ]
  4. Peak ocrelizumab milk concentration [ Time Frame: Over 60 days after the mother's first post-partum ocrelizumab infusion ]
  5. Time to reach peak ocrelizumab milk concentration [ Time Frame: Over 60 days after the mother's first post-partum ocrelizumab infusion ]
  6. Estimated maximum oral daily infant dosage (MDID) [ Time Frame: Over 60 days after the mother's first post-partum ocrelizumab infusion ]
  7. Serum concentration of ocrelizumab in the infant [ Time Frame: 30 days after the mother's first post-partum ocrelizumab infusion ]
  8. Mean titers of antibody immune responses to vaccination to common childhood immunizations [ Time Frame: 1 month after the first dose of MMR vaccine or at month 13 (±14 days) in case MMR vaccine is not planned to be administered ]
  9. Proportion of infants with positive humoral response (seroprotective titers; as defined for the individual vaccine) to vaccines [ Time Frame: 1 month after the first dose of MMR vaccine, or at month 13 (±14 days) in case MMR vaccine is not planned to be administered ]
  10. Rate and nature of adverse events in the infant [ Time Frame: Baseline up to 16 months ]
  11. Rate and nature of adverse events in the mother [ Time Frame: Baseline up to 16 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 willing to provide breastmilk samples
  • Woman has a diagnosis of MS or CIS (in line with the locally approved indications)
  • Woman has delivered a term singleton infant (≥37 weeks gestation)
  • Infant is between 2-24 weeks of life
  • For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure to ocrelizumab occurred more than 3 months before the last menstrual period (LMP) and was given at the approved dose of 2 x 300 mg or 1 x 600 mg
  • Woman agrees to use acceptable contraceptive methods during the study

Exclusion Criteria related to the Mother:

  • Received last dose of ocrelizumab <3 months before the LMP or during pregnancy
  • Active infections (may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved)
  • Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
  • Known active malignancies, or being actively monitored for recurrence of malignancy
  • History of breast implants, breast augmentation, breast reduction surgery or mastectomy
  • Prior or current history of chronic alcohol abuse or drug abuse
  • Any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, would compromise the woman's ability to participate in this study
  • Positive screening tests for hepatitis B
  • Treatment with a DMT for CIS or MS during pregnancy and/or first weeks post-partum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids
  • Treatment with drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant
  • Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the LMP

Exclusion Criteria related to the Infant:

  • >24 weeks of life at the time of the mother's first dose of ocrelizumab
  • Any abnormality that may interfere with breastfeeding or milk absorption
  • Active infection (may be included once the infection resolves)
  • Any other medical condition or abnormality that, in the opinion of the investigator, could compromise the infant's ability to participate in this study
  • At least one documented brief resolved unexplained event (BRUE), as defined by the 2016 Guidelines of the American Academy of Pediatrics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04998851


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: MN42989 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94117
United States, Massachusetts
Brigham and Womens Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z1
France
Hopital Pierre Wertheimer - Hopital Neurologique Not yet recruiting
Bron, France, 69677
Germany
St. Josef Hospital; Zentralapotheke Not yet recruiting
Troisdorf, Germany, 53842
Italy
Fondazione Ptv Policlinico Tor Vergata Not yet recruiting
Roma, Lazio, Italy, 00133
Spain
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Switzerland
Neurocenter of Southern Switzerland Not yet recruiting
Lugano, Switzerland, 6900
United Kingdom
Queen Mary University of London Not yet recruiting
London, United Kingdom, EC1M 6BQ
Salford Royal NHS Foundation Trust Not yet recruiting
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Hoffmann-La Roche
PPD
LabCorp
Illingworth
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04998851    
Other Study ID Numbers: MN42989
2021-000063-79 ( EudraCT Number )
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
ocrelizumab, OCREVUS, breastmilk transfer, breast milk transfer, lactation
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs