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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 : Not yet recruiting
First Posted : August 10, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
PPD
LabCorp
Illingworth
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
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

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 post-partum ]

Secondary Outcome Measures :
  1. B cell levels (CD19+ cells) in the infant [ Time Frame: Week 6 post-partum ]
  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 post-partum ]
  4. 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 ]
  5. 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 ]
  6. 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) ]
  7. Rate and nature of adverse events in the infant [ Time Frame: Baseline up to 17 months ]
  8. Rate and nature of adverse events in the mother [ Time Frame: Baseline up to 17 months ]
  9. Infant characteristics at birth (body weight) [ Time Frame: At birth ]
  10. Infant characteristics at birth (head circumference) [ Time Frame: At birth ]
  11. Infant characteristics at birth (body length) [ Time Frame: At birth ]
  12. Proportion of pregnancies resulting in live births, therapeutic abortions, or stillbirth [ Time Frame: At birth ]


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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 ≤26 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 >26 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 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 www.roche.com/about_roche/roche_worldwide.htm 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
San Francisco, California, United States, 94117
United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
France
Hopital Pierre Wertheimer - Hopital Neurologique
Bron, France, 69677
Hôpital de la Pitié Salpétrière
Paris, France, 75013
Germany
St. Josef Hospital; Zentralapotheke
Troisdorf, Germany, 53842
Italy
Fondazione Ptv Policlinico Tor Vergata
Roma, Lazio, Italy, 00133
Spain
Hospital Ramón y Cajal;Servicio de Neumología
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
Neurocenter of Southern Switzerland
Lugano, Switzerland, 6900
United Kingdom
Queen Mary University of London
London, United Kingdom, EC1M 6BQ
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Hoffmann-La Roche
PPD
LabCorp
Illingworth
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: September 22, 2021
Last Verified: September 2021

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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