A multicenter, open-label, prospective study to assess the concentration of bimekizumab in mature breast milk from mothers receiving treatment with Bimzelx® (bimekizumab)
This research study is looking into Bimzelx, a medicine used for conditions like hidradenitis suppurativa, axial spondyloarthritis, moderate to severe plaque psoriasis, and psoriatic arthritis. The main goal is to find out how much of this medicine passes into a mother's breast milk. This information is important for doctors and mothers to understand if it's safe for babies to breastfeed when the mother is taking Bimzelx. The study will involve mothers who are already using Bimzelx and collecting samples of their breast milk at different times. They will also keep an eye on how the mothers are feeling to make sure the treatment is not causing any unexpected side effects.
At a glance
What is this study about?
This study is designed to help us understand a medicine called Bimzelx, which is used to treat several long-term health conditions such as certain types of arthritis, skin conditions like psoriasis, and a skin problem called hidradenitis suppurativa. Many people find relief from their symptoms with this medication.
For mothers who are taking Bimzelx and would like to breastfeed, it's very important to know if the medicine passes into their breast milk and, if so, how much. This study aims to gather this vital information. By carefully measuring the levels of Bimzelx in breast milk samples, researchers can figure out how much of the medicine a baby might receive through breastfeeding.
The findings from this study will help healthcare professionals give the best advice to mothers using Bimzelx about breastfeeding their babies. It contributes to making sure that both mothers and their infants are kept as safe and healthy as possible.
Key takeaways
- This study investigates Bimzelx levels in breast milk.
- It helps doctors give advice on breastfeeding while taking Bimzelx.
- Mothers with specific conditions treated with Bimzelx can participate.
- Participation involves providing breast milk samples and health monitoring.
- The goal is to ensure safety for breastfeeding mothers and their babies.
Who may be eligible?
This study is for women who are at least 18 years old and are currently receiving treatment with Bimzelx for certain health conditions.
You would need to be a mother who is breastfeeding to take part. The study needs to measure the medicine in your breast milk, so you must be able to provide these samples.
Specifically, the researchers are looking for mothers who are being treated for hidradenitis suppurativa, axial spondyloarthritis, moderate to severe plaque psoriasis, or psoriatic arthritis.
- Are you 18 years old or older?
- Are you a mother who is currently breastfeeding?
- Are you receiving treatment with Bimzelx?
- Are you being treated for hidradenitis suppurativa, axial spondyloarthritis, moderate to severe plaque psoriasis, or psoriatic arthritis?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would continue to receive your Bimzelx treatment as prescribed. The main part of your involvement would be providing samples of your breast milk. These samples will be collected at specific times on certain days, such as Day 1, and then on Days 2, 3, 5, 7, 9, 11, 13, and 15 after a dose. Depending on your regular dosing schedule (every 4 or 8 weeks), you might also be asked for samples around Day 29 or Day 57.
The research team will also keep track of how you are feeling throughout the study to monitor for any side effects. The total duration of your participation will depend on your specific Bimzelx dosing schedule and the follow-up period required by the study.
Potential risks and benefits
Locations (2)
- —Spain
- —Germany
Common questions
What is Bimzelx used for?
Bimzelx is a medicine for conditions like certain types of arthritis (psoriatic arthritis, axial spondyloarthritis) and skin conditions such as plaque psoriasis and hidradenitis suppurativa.
Why is this study important for mothers?
It helps us understand how much Bimzelx gets into breast milk, which is crucial for doctors to advise breastfeeding mothers on the safety of their babies.
Will I need to change my Bimzelx treatment?
No, you will continue with your regular Bimzelx treatment as prescribed by your doctor.
What will I have to do if I join the study?
You will need to provide breast milk samples at specific times over several days, and the study team will check on your health.
How long will I be in the study?
The length of time you participate will depend on your Bimzelx dosing schedule and the study's follow-up plan.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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