🏛️ Verified NIH Record • Updated 2026-07-14

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS) (NCT05123703)

A Phase III Multicenter, Randomized, Double-blind, Double-dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UC San Diego — La Jolla, California

Age range: 10 Years to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (71 Sites)

Showing the first 25 of 71 sites.

  • UC San Diego — La Jolla, California
  • Children's Hospital Colorado — Aurora, Colorado
  • Children's National Hospital — Washington D.C., District of Columbia
  • Johns Hopkins Medicine — Baltimore, Maryland
  • Boston Children's Hospital Central Pharmacy — Boston, Massachusetts
  • Washington University — St Louis, Missouri
  • Cleveland Clinic, Mellen Center for Multiple Sclerosis — Cleveland, Ohio
  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company — Columbus, Ohio
  • The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
  • Baylor College of Medicine/Texas Children's Hospital — Houston, Texas
  • Centro de Investigaciones Médicas Tucuman — San Miguel de Tucumán,
  • Royal Children's Hospital Melbourne - PIN — Parkville, Victoria
  • Medizinische Universität Wien — Vienna,
  • UZ Gent — Ghent,
  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME — Brasília, Federal District
  • Instituto de Neurologia de Curitiba — Curitiba, Paraná
  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR — Porto Alegre, Rio Grande do Sul
  • Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul
  • CPQuali Pesquisa Clínica Sao Paulo — São Paulo, São Paulo
  • Inst. Da Criança- Faculdade de Medicina Usp — São Paulo,
  • Children's Hospital of Eastern Ontario — Ottawa, Ontario
  • The Hospital for Sick Children — Toronto, Ontario
  • Astra Kliinik — Tallinn,
  • Tartu University Hospital — Tartu,
  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer — Bron, Rhône

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Relapsing-remitting Multiple Sclerosis

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗