Phase III Study of ocrelizumab in children & adolescents with MS
Research type
Research Study
Full title
A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLEDUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
IRAS ID
301736
Contact name
Cheryl Hemingway
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2020-004128-41
Duration of Study in the UK
7 years, 10 months, 19 days
Research summary
This clinical trial is recruiting patients aged ≥10 to < 18 years who has relapsing-remitting multiple sclerosis (RRMS). The trial will evaluate the safety and efficacy of ocrelizumab compared with fingolimod over a duration of at least 96 weeks.
Current paediatric treatments for MS are similar to those used in adults. Such treatment focus on treating acute relapses, modifying disease and treating MS symptoms. There is a need for developing new therapies in this patient population due to intolerance, toxicity, persisting relapses and non-adherence to treatments.
Ocrelizumab is an investigational drug for paediatrics however it is currently used for adults and is shown to be safe and effective. About 233 children and adolescents with RRMS will take part in this study. Participants will be in the study for at least 2 years and up to 6 years or longer and will have clinic visits every 3 months with an additional shorter clinic visits around 2 weeks before each IV infusion.
There are 4 parts to the study, screening, blinded treatment Part1, Open-Label Part 2, and Safety follow up. Participants will be randomised into a treatment group to receive either ocrelizumab every 6 months by infusion or fingolimod orally once a day. All participants will also take a dummy of the other type of drug. There will also be an open-label treatment part 2 of the study where all patients will be given ocrelizumab.
Study procedures include blood & urine testing, brain MRI scan, questionnaires. vital signs, physical exams, examination of body development, weight/height, neurological examination, urine sample, ECG, telephone follow up, eye exams, optional hand/wrist x-ray and lumbar puncture if required for safety reasons.
This is a phase 3, multicentre, randomised double blind double dummy study sponsored by F. Hoffman-La Roche Ltd.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0269
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion