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A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy (MINORE)

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ClinicalTrials.gov Identifier: NCT04998812
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : November 17, 2022
Sponsor:
Collaborators:
PPD
Laboratory Corporation of America
Illingworth Research Group
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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 Potentially Exposed To Ocrelizumab During Pregnancy
Actual Study Start Date : April 13, 2022
Estimated Primary Completion Date : April 3, 2023
Estimated Study Completion Date : January 22, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Women with CIS or MS
Women with CIS or MS (in line with the locally approved indications) receiving commercial ocrelizumab up to 6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13), due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice.
Drug: Ocrelizumab
Post-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling.




Primary Outcome Measures :
  1. Proportion of infants with B cell levels (CD19+ cells) below the lower limit of normal (LLN) [ Time Frame: Week 6 of life ]

Secondary Outcome Measures :
  1. B cell levels (CD19+ cells) in the infant [ Time Frame: Week 6 of life ]
  2. Serum concentration of ocrelizumab in the umbilical cord blood at birth [ Time Frame: Within 1 hour after delivery ]
  3. Serum concentration of ocrelizumab in the infant [ Time Frame: Week 6 of life ]
  4. Serum concentration of ocrelizumab in the mother [ Time Frame: During the second trimester (week 26), third trimester (week 36) and at delivery (within 24 hours after delivery) ]
  5. Rate and nature of adverse events in the infant [ Time Frame: Baseline up to 17 months ]
  6. Rate and nature of adverse events in the mother [ Time Frame: Baseline up to 17 months ]
  7. Infant characteristics at birth (body weight) [ Time Frame: At birth ]
  8. Infant characteristics at birth (head circumference) [ Time Frame: At birth ]
  9. Infant characteristics at birth (body length) [ Time Frame: At birth ]
  10. Proportion of pregnancies resulting in live births, therapeutic abortions, or stillbirth [ Time Frame: At birth ]
  11. Mean titers of antibody immune responses to Measles, Mumps, and Rubella (MMR) Vaccination [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  12. Proportion of infants with positive humoral response to Measles, Mumps, and Rubella (MMR) Vaccination [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  13. Mean titers of antibody immune responses to Diphtheria-Tetanus-Pertussis Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  14. Proportion of infants with positive humoral response to Diphtheria-Tetanus-Pertussis Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  15. Mean titers of antibody immune responses to Haemophilus influenzae type B Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  16. Proportion of infants with positive humoral response to Haemophilus influenzae type B Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  17. Mean titers of antibody immune responses to Hepatitis B Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  18. Proportion of infants with positive humoral response to Hepatitis B Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  19. Mean titers of antibody immune responses to Pneumococcal conjugate Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]
  20. Proportion of infants with positive humoral response to Pneumococcal conjugate Vaccine [ Time Frame: Up to 1 month after the first or second dose of MMR vaccine, or at Month 13 of age if the MMR vaccine is not planned to be administered ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with CIS or MS (in line with the locally approved indications) receiving commercial ocrelizumab up to 6 months before the LMP or during the first trimester (up to gestational week 13) of pregnancy
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MS or CIS (in line with the locally approved indications)
  • Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment
  • Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
  • Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy

Exclusion Criteria:

  • Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
  • Gestational age at enrolment >30 weeks
  • Non-singleton pregnancy
  • Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
  • Lack of access to ultrasound pre-natal care as part of standard clinical practice
  • Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
  • Pre-pregnancy body mass index >35 kg/m2
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
  • Significant and uncontrolled disease that may preclude a woman from participating in the study
  • Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies
  • Prior or current history of alcohol or drug abuse, or current use of tobacco
  • Positive screening tests for hepatitis B
  • Treatment with drugs known to have teratogenic effects
  • Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
  • Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
  • Treatment with natalizumab within 12 weeks prior to the LMP
  • Treatment with teriflunomide within the last two years, unless measured plasma concentrations are <0.02 mg/L. If levels are >0.02 mg/L or not known, an accelerated elimination procedure is required
  • Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP

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): NCT04998812


Contacts
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Contact: Reference Study ID Number: MN42988 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94117
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
France
Hopital Pierre Wertheimer - Hopital Neurologique Recruiting
Bron, France, 69677
Hôpital de la Pitié Salpétrière Recruiting
Paris, France, 75013
Germany
St. Josef Hospital GmbH Recruiting
Bochum, Germany, 44791
Universitaetsklinikum Carl Gustav Carus an der TU Dresden Recruiting
Dresden, Germany, 01307
MultipEL Studies - Institut für klinische Studien Recruiting
Hamburg, Germany, 22179
Spain
Hosp. Clinico San Carlos Recruiting
Madrid, Spain, 28040
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
United Kingdom
Queen Mary University of London Recruiting
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Hoffmann-La Roche
PPD
Laboratory Corporation of America
Illingworth Research Group
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04998812    
Other Study ID Numbers: MN42988
2021-000062-14 ( EudraCT Number )
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hoffmann-La Roche:
ocrelizumab, OCREVUS, placental transfer, pregnancy
Additional relevant MeSH terms:
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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