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

  • Multiple Sclerosis (MS)
Trial Status:

Recruiting

This trial runs in
Countries
  • Germany
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT04998851 2021-000063-79 MN42989

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 4 Phase
      NCT04998851 , MN42989 , 2021-000063-79 Trial Identifier
      Ocrelizumab Treatments
      Multiple Sclerosis, Clinically Isolated Syndrome Condition
      Official Title

      A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

      Eligibility Criteria

      Female Gender
      ≥18 Years & ≤ 40 Years Age
      No Healthy Volunteers
      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

      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

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