Ongoing Clinical Trials for Myositis
Currently, there is 1 ongoing clinical trial related to myositis. This trial is investigating the safety of prednisolone use during breastfeeding for mothers with inflammatory conditions, including myositis, by measuring how much of the medication passes into breast milk and the infant’s bloodstream.
Clinical trial locations
Study on Prednisolone Transfer into Breast Milk and Infant Plasma for Mothers with Rheumatoid Arthritis and Other Inflammatory Conditions
This clinical trial is designed to help doctors understand how safe it is for mothers to breastfeed while taking prednisolone, a medication commonly used to treat inflammatory conditions. The study focuses on measuring how much of this medication passes from the mother into her breast milk and then into her baby’s bloodstream.
Main focus and goal: The primary aim of this research is to measure the concentration of prednisolone in breast milk and in the blood of breastfed infants. Researchers will collect breast milk and blood samples from mothers one hour after they take their prednisolone dose, and blood samples from infants two hours after breastfeeding. The study will also measure cortisol levels in the infant’s blood at the same time. This information will help healthcare providers make better-informed decisions about treatment options for breastfeeding mothers with inflammatory conditions.
Investigational drug: The medication being studied is prednisolone, a corticosteroid that reduces inflammation in the body. It works by mimicking hormones naturally produced by the adrenal glands and is used to treat various inflammatory conditions. In this trial, mothers are taking oral doses of up to 50 mg per day.
Who can participate: This study is open to breastfeeding women who meet the following criteria:
- Must be 18 years of age or older
- Currently breastfeeding while taking prednisolone for any health condition
- Taking doses of prednisolone up to 50 mg per day
- Both the mother and the child’s father must sign an informed consent form, showing they understand and agree to participate in the study
Who cannot participate: The study excludes individuals who:
- Are not women
- Are not currently breastfeeding
- Do not have inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, myositis, psoriatic arthritis, or inflammatory bowel disease
The trial is being conducted in Sweden and is expected to conclude by December 31, 2025. Throughout the study, the health and safety of both mothers and infants will be closely monitored to ensure their well-being.
Summary
This single clinical trial represents an important step in understanding medication safety for breastfeeding mothers with inflammatory conditions. The study is particularly relevant for women with myositis who need ongoing treatment with prednisolone but wish to continue breastfeeding. By measuring drug transfer into breast milk and infant blood levels, this research aims to provide evidence-based guidance for healthcare providers treating mothers with inflammatory conditions. The trial is taking place in Sweden and focuses on a commonly prescribed anti-inflammatory medication, prednisolone, which may benefit not only mothers with myositis but also those with other inflammatory conditions.