An Open-Label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis
Multiple sclerosis (MS) is a condition that affects the brain and spinal cord, causing flare-ups of symptoms like numbness, weakness, and balance problems. Relapsing-remitting MS (RRMS) means these symptoms come and go. Ocrelizumab is a medicine already used for adults, usually given as a slow drip into a vein. This study looks at giving it as a quick injection under the skin (a subcutaneous injection) for children and teenagers. Researchers want to find out how young bodies process the medicine, how it affects certain immune cells, and whether it causes any unwanted side effects. The goal is to see if a simple injection is a safe, gentle, and effective alternative to long hospital drips for young people living with MS.
At a glance
What is this study about?
Multiple sclerosis (MS) happens when the body's immune system mistakenly attacks the nerves in the brain and spinal cord. In relapsing-remitting MS, people experience periods where symptoms flare up, followed by times of recovery. Ocrelizumab is an established treatment that works by calming specific immune cells (called B cells) to help prevent these nerve attacks.
Currently, ocrelizumab is usually given through a vein over several hours in hospital. This study is testing an injection given just under the skin for children and teenagers. An injection takes only a few minutes, which could make treatment much easier, quicker, and less stressful for young people and their families.
Doctors are carefully measuring how the drug travels through a younger person's body. They will test how much medicine enters the blood, how long it stays active, and how effectively it lowers the immune cells responsible for MS attacks. They will also monitor heart health, blood pressure, and general well-being.
Understanding the right dose and safety profile in younger patients is crucial. If this study is successful, it could help lead to a faster and more convenient treatment option for children living with relapsing-remitting MS across the UK.
Key takeaways
- Tests an under-the-skin injection of ocrelizumab for children and teenagers with relapsing-remitting MS.
- Aims to find out how young bodies absorb and process the medicine.
- Could provide a quicker, simpler alternative to long hospital drips.
- Involves regular hospital check-ups, heart traces, and blood tests to ensure safety.
- Participation is completely voluntary and will not affect standard NHS care.
Who may be eligible?
This trial is specifically for children and teenagers who have been diagnosed with relapsing-remitting multiple sclerosis (RRMS). Both boys and girls can take part, provided they meet the specific age group set by the study team.
Because the study closely monitors how young bodies handle the medicine, participants need to be well enough to attend regular hospital appointments. The medical team will check each child's health history, including past treatments, to ensure the trial is safe for them.
Children with certain active infections or other major health conditions may not be able to join. A parent or guardian will need to give permission, and young people will also be asked to agree if they are happy to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Diagnosed with relapsing-remitting multiple sclerosis (RRMS)
- A child or teenager within the study's age group
- Able to attend regular hospital visits and check-ups
- Willing to receive a medicine by injection under the skin
- Has consent from a parent or legal guardian to take part
What does participation involve?
If your child joins the study, they will receive ocrelizumab as an injection under the skin, rather than through an intravenous drip.
Before treatment begins, the medical team will carry out health checks, such as physical examinations, heart traces (ECGs), and routine blood tests. After receiving the injection, your child will attend regular hospital appointments so doctors can track their health. Blood samples will be taken at set times to see how the medicine moves through the body and how it affects immune cells. The study doctors will also check for any side effects or skin reactions. The research team will explain the full schedule of visits and the total length of the trial before you decide to take part.
Potential risks and benefits
Locations (3)
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
How is the study medicine given?
It is given as an injection just under the skin (subcutaneous), which takes far less time than a traditional hospital drip.
Is ocrelizumab a new medicine?
No, it is already widely used to treat adults with MS. This study is finding out the best and safest way to use it for children and teenagers.
Will having the injection hurt?
Your child might feel a brief pinch or sting, and there may be mild redness or soreness at the injection site, but this usually settles quickly.
Do we have to pay for the trial treatment?
No, all study medicines, tests, and hospital appointments are provided free of charge, and help with travel costs is often available.
Can we leave the study early if we change our minds?
Yes, taking part is entirely your choice. You and your child can stop at any point, and your standard NHS treatment will continue as normal.
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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