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Be Part of Research - Trial Details - A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
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A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

Not Recruiting

Open to: ALL

Age: 10.0 - 17.0

Cambridge London Edinburgh

Medical Conditions

Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2022 Jul 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.

Intervention Arm Group : Ocrelizumab;

Intervention Type : OTHER
Intervention Description : Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.

Intervention Arm Group : Fingolimod;

Intervention Type : DRUG
Intervention Description : Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).

Intervention Arm Group : Fingolimod;

Intervention Type : OTHER
Intervention Description : Fingolimod matching placebo will be administered daily as a capsule.

Intervention Arm Group : Ocrelizumab;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Addenbrookes Hospital
    Cambridge
    CB2 0QQ
  • Great Ormond Street Hospital for Children
    London
    WC1N 3JH
  • Royal Hospital for Children and Young People
    Edinburgh
    EH51


The study is sponsored by Hoffmann-La Roche and is in collaboration with PPD DEVELOPMENT, LP.




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Read full details for Trial ID: NCT05123703
Last updated 08 April 2025

This page is to help you find out about a research study and if you may be able to take part

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