Ongoing Clinical Trials for Clinically Isolated Syndrome
This article provides information about ongoing clinical trials for Clinically Isolated Syndrome (CIS), a neurological condition that can be a precursor to Multiple Sclerosis. Currently, there is 1 clinical trial examining the effects of treatment during pregnancy on infants. The trial is being conducted in Germany and Spain.
Clinical trial locations
- Germany
- Spain
Study on B-Cell Levels in Infants Exposed to Ocrelizumab During Pregnancy for Mothers with Multiple Sclerosis or Clinically Isolated Syndrome
This clinical trial focuses on examining the health of infants whose mothers took Ocrelizumab during pregnancy while being treated for Multiple Sclerosis or Clinically Isolated Syndrome. The study aims to understand how exposure to this medication during pregnancy might affect the baby’s immune system development.
Main inclusion criteria:
- Pregnant women between 18 and 40 years old
- Confirmed diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome
- Single-baby pregnancy at or before the 30th week of gestation
- Completed first and second pregnancy ultrasounds before enrollment
- Last exposure to Ocrelizumab occurred up to 6 months before the last menstrual period before pregnancy, or during the first 13 weeks of pregnancy
Main exclusion criteria:
- Women without a diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome
- Women outside the specified age range
- Individuals who do not meet the study’s gender requirements
- Individuals considered part of vulnerable populations requiring special protection
Focus and goals:
The trial’s primary goal is to evaluate whether infants exposed to Ocrelizumab during pregnancy show changes in their B-cell levels after birth. B-cells are white blood cells that play an important role in helping the body fight infections. Researchers will measure B-cell levels when infants are six weeks old to determine if they are lower than normal. The study will also track the amount of Ocrelizumab in the baby’s blood at birth and monitor how well the infants respond to standard childhood vaccinations.
Throughout the pregnancy, blood samples will be collected from mothers at different stages to measure Ocrelizumab levels. At birth, researchers will collect umbilical cord blood and record the infant’s weight, head size, and length. The study will continue to monitor both mothers and infants for any side effects or health issues, including infections and hospitalizations. This comprehensive approach will help researchers understand the potential impact of Ocrelizumab exposure during pregnancy on infant health and development.
Investigational drug:
The study focuses on Ocrelizumab, a monoclonal antibody that targets specific cells in the immune system. This medication is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. Ocrelizumab works by targeting and reducing CD20-positive B-cells, which are believed to contribute to the abnormal immune response seen in conditions affecting the brain and spinal cord. The medication is currently approved for treating Multiple Sclerosis and Clinically Isolated Syndrome in various regions.
Summary
Currently, there is one clinical trial available for patients with Clinically Isolated Syndrome, focusing on maternal and infant health during pregnancy. This trial is being conducted in two European countries: Germany and Spain. The research concentrates specifically on Ocrelizumab, examining its effects when women are exposed to the medication before or during early pregnancy. The study represents an important effort to understand how treatments for neurological conditions may affect pregnancy outcomes and infant development, particularly regarding immune system function. Patients interested in this trial should consult with their healthcare providers to determine eligibility and discuss participation options.
