A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
This research study is for children and teenagers aged 10 to 17 who have a type of multiple sclerosis (MS) called relapsing-remitting MS (RRMS). The study aims to find out how safe and effective a new medicine called ocrelizumab is compared to an existing medicine called fingolimod. We want to see if ocrelizumab can help control MS symptoms. Participants will receive either ocrelizumab or fingolimod, and neither the patient nor the doctor will know which one they are getting during the main part of the study. After this, participants might have the option to continue receiving ocrelizumab in an extended part of the study. This trial helps doctors understand if ocrelizumab could be a good treatment option for young people with RRMS.
At a glance
What is this study about?
This study is designed to explore a new treatment called ocrelizumab for young people aged 10 to 17 who have a specific type of multiple sclerosis, known as relapsing-remitting MS (RRMS). RRMS is a condition where symptoms can come and go, affecting the brain and spinal cord. We want to understand if ocrelizumab is a safe and effective option for these young patients, helping to manage their condition and improve their quality of life.
To do this, we are comparing ocrelizumab with another medicine already used for MS, called fingolimod. Participants will be split into groups, and they will receive either ocrelizumab or fingolimod. This comparison is really important because it helps us see how well the new treatment works against an established one. The study is designed so that neither the patient nor their doctor will know which treatment they are receiving, which helps make the results as fair and unbiased as possible.
The main part of the study will last for a flexible period, but for at least 24 weeks after the last person joins. After completing this main part, eligible participants might have the chance to join an optional longer-term part of the study, where they would receive ocrelizumab for at least 144 weeks. This longer period helps us learn more about the long-term safety and effects of ocrelizumab.
Key takeaways
- This study is for children and teenagers (10-17 years) with relapsing-remitting MS (RRMS).
- It compares a new medicine, ocrelizumab, with an existing one, fingolimod.
- The main aim is to check the safety and effectiveness of ocrelizumab in young people.
- Participants will receive either ocrelizumab (by IV drip) or fingolimod (daily tablet).
- Neither patient nor doctor will know which treatment is given during the main study period.
- Optional long-term treatment with ocrelizumab may be available after the main study.
Who may be eligible?
This study is looking for children and teenagers between 10 and 17 years old who have been diagnosed with relapsing-remitting multiple sclerosis (RRMS). To join, your child must have been diagnosed with RRMS according to specific medical guidelines and their MS must be currently active, meaning they've either had a recent relapse or signs of new MS activity on a recent MRI scan. They also need to weigh at least 25 kilograms.
There are certain health conditions that would prevent someone from joining. For example, if your child has other neurological disorders that might be mistaken for MS, serious uncontrolled illnesses, or a known active infection, they would not be able to participate. Also, any significant heart problems or unusual findings on a heart test (ECG) would mean they couldn't join.
If your child completes the main part of the study, they might be able to continue in an optional extension part, as long as their doctor believes switching to ocrelizumab would be beneficial for them. However, if they leave the study early during the initial phase, they wouldn't be able to join this optional longer-term 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.
- Is your child aged between 10 and 17 years old?
- Does your child have a confirmed diagnosis of relapsing-remitting MS?
- Has your child had a recent MS relapse or signs of new MS activity on an MRI scan?
- Does your child weigh at least 25 kilograms?
- Does your child have any serious heart conditions or other major uncontrolled illnesses?
What does participation involve?
If your child takes part in this study, they will either receive ocrelizumab, which is given by a drip (IV infusion) every 24 weeks, or fingolimod, which is a tablet taken daily. Neither you, your child, nor the study doctor will know which medicine your child is receiving during the main part of the study, which helps ensure fairness. This main treatment period will last for at least 24 weeks from when the last person joins the study. Throughout this time, your child will have regular visits to the clinic for check-ups, tests, and to receive their medication (if it's the infusion).
After the main study period, if eligible and with your agreement, your child might be offered the chance to continue with ocrelizumab in an optional, longer-term phase of the studycalled an 'open-label extension'. In this extension, everyone receives ocrelizumab, and you and the doctor will know what medicine your child is getting. This extension period will last for at least 144 weeks, with continued clinic visits and monitoring. The total duration of participation would be the flexible main period plus the extension if applicable.
Potential risks and benefits
Locations (102)
- UC San DiegoVerified postcodeLa Jolla, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Children's Hospital ColoradoVerified postcodeAurora, United States
- Children's National HospitalVerified postcodeWashington D.C., United States
- Johns Hopkins MedicineVerified postcodeBaltimore, United States
- Boston Children's Hospital Central PharmacyVerified postcodeBoston, United States
- Washington UniversityVerified postcodeSt Louis, United States
- Robert Wood Johnson Medical SchoolVerified postcodeNew Brunswick, United States
- Cleveland Clinic, Mellen Center for Multiple SclerosisVerified postcodeCleveland, United States
- The Boster Center for Multiple Sclerosis a Singlepoint Healthcare CompanyVerified postcodeColumbus, United States
- The Children's Hospital of PhiladelphiaVerified postcodePhiladelphia, United States
- Baylor College of Medicine/Texas Children's HospitalVerified postcodeHouston, United States
Common questions
What is relapsing-remitting MS (RRMS)?
RRMS is a type of multiple sclerosis where symptoms appear in 'relapses' or 'attacks', followed by periods of recovery. These symptoms can be varied and affect different parts of the body.
What is ocrelizumab?
Ocrelizumab is a medicine that works to slow down the progression of MS by targeting specific immune cells that are thought to contribute to the disease. It's currently being studied for use in young people.
What is fingolimod?
Fingolimod is an existing medication already approved for treating MS. It works by keeping certain immune cells out of the brain and spinal cord, which helps reduce MS attacks.
What does 'double-blind, double-dummy' mean?
It means that neither the patient, their family, nor the doctors involved will know whether the patient is receiving the active ocrelizumab or the active fingolimod. This helps ensure the study results are fair and objective.
How often will my child need to visit the clinic?
The frequency of visits will depend on which treatment your child receives, but there will be regular appointments for check-ups, assessments, and to receive or pick up medication. Your study team will give you a detailed schedule.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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