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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
EU CTIS ID: 2023-506516-40-00
What this study is testing
To demonstrate non-inferiority of ocrelizumab compared with fingolimod, based on Protocol-defined annualized relapse rate (ARR)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 10 to <18 years at randomization with Body weight >=25 kilograms
- At least one relapse during the year prior to screeningAt least one relapse during the year prior to screening or two relapses in the previous two years prior to screening or evidence of at least one Gd enhancing lesion on MRI within 6 months prior to randomization (including screening MRI) For Germany, the criterion is as follows: Highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy, or patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with at least one Gadolinium enhancing lesion on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI or two relapses in the previous two years prior to screening or evidence of at least one Gd enhancing lesion on MRI within 6 months prior to randomization (including screening MRI) For Germany, the criterion is as follows: Highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy, or patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with at least one Gadolinium enhancing lesion on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) in accordance with the international pediatric multiple sclerosis study group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 (or the most current revision of the IPMSSG criteria or McDonald criteria at the time of study start) and confirmed by the Independent Pediatric MS Review Committee prior to randomization
- Children and adolescents must have received all childhood vaccinations as per local and/or national recommendations for childhood vaccination against infectious diseases
- Expanded disability status scale (EDSS) at screening: 0-5.5, both inclusive
- Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 24 weeks after the final dose of ocrelizumab/ocrelizumab placebo and for 2 months after the final dose of fingolimod/fingolimod placebo
You likely can't join if
- Aquaporin-4 positive and/or myelin oligodendrocyte glycoprotein antibody positive
- Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to Day 1 visit or oral anti-infective agents within 2 weeks prior to Day 1 visit or History or known presence of recurrent or chronic infection
- Receipt of any type of vaccine (e.g., live or live-attenuated vaccine, non-live) within 6 weeks prior to treatment allocation
- History of symptomatic bradycardia, recurrent syncope, significant QT prolongation, Patients with severe cardiac arrhythmias
- Exclusion criteria related to prior treatments for MS, as per protocol
- Exclusion Criteria Related to Laboratory Findings, as per protocol
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Canada
- Brazil
- Turkey
- Ukraine
- Morocco
- Mexico
- India
- Korea, Republic of
- China
- Switzerland
- Australia
- United States
- Serbia
- United Kingdom
- Russian Federation
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Canada; Brazil; Turkey; Ukraine; Morocco and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.