Clinically isolated syndrome – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 10:33:00 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Clinically isolated syndrome – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on B-Cell Levels in Infants Exposed to Ocrelizumab During Pregnancy for Mothers with Multiple Sclerosis or Clinically Isolated Syndrome https://clinicaltrials.eu/trial/study-on-b-cell-levels-in-infants-exposed-to-ocrelizumab-during-pregnancy-for-mothers-with-multiple-sclerosis-or-clinically-isolated-syndrome/ Wed, 29 Apr 2026 14:30:00 +0000 https://clinicaltrials.eu/trial/study-on-b-cell-levels-in-infants-exposed-to-ocrelizumab-during-pregnancy-for-mothers-with-multiple-sclerosis-or-clinically-isolated-syndrome/ This clinical trial is focused on studying the effects of the medication Ocrelizumab, known by its code name RO4964913, on infants who may have been exposed to it during pregnancy. The study is particularly interested in mothers with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS), which are conditions that affect the brain and spinal cord. Ocrelizumab is a treatment that is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate whether infants exposed to Ocrelizumab during pregnancy show any changes in their B-cell levels after birth. B-cells are a type of white blood cell that plays a crucial role in the immune system by helping the body fight infections. The study will monitor the infants’ B-cell levels at six weeks of age to see if they are lower than normal. Additionally, the study will measure the amount of Ocrelizumab in the infants’ blood and in the umbilical cord at birth, as well as in the mothers’ blood during pregnancy and at delivery.

Throughout the study, researchers will also observe the infants’ responses to common childhood vaccinations and monitor for any side effects or health issues in both the mothers and infants. The study aims to gather information on the health and development of the infants, including their weight, head size, and length at birth, as well as the outcomes of the pregnancies, such as live births or any complications. This information will help understand the potential impact of Ocrelizumab exposure during pregnancy on infant health.

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