🏛️ Verified NIH Record • Updated 2025-12-05

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (NCT04075266)

An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

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

This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Who can join: Review the eligibility criteria below.

Location: University of Colorado Denver Childrens Hospital Rocky Mountain MS Center — Aurora, Colorado

Age range: 10 Years to 18 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 (12 Sites)

  • University of Colorado Denver Childrens Hospital Rocky Mountain MS Center — Aurora, Colorado
  • Childrens National Health Center — Washington D.C., District of Columbia
  • Boston Childrens Hospital — Boston, Massachusetts
  • Washington Universtiy school of Medicine — St Louis, Missouri
  • Cleveland Clinic — Cleveland, Ohio
  • Ospedale Pediatrico Bambino Gesù — Rome, Lazio
  • Azienda Ospedaliera Sant'Andrea — Rome, Lazio
  • AOU Policlinico V. Emanuele - P.O G. Rodolico — Catania, Sicily
  • Uniwersyteckie Centrum Kliniczne — Gda?sk,
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Późna,
  • Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego — Warsaw,
  • Instytut Pomnik Centrum Zdrowia Dziecka — Warsaw,

💰 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.

💡 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 ↗