Ocrelizumab vs Fingolimod for Pediatric Multiple Sclerosis
(Operetta 2 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug fingolimod for pediatric multiple sclerosis?
Fingolimod has been shown to be effective for children with relapsing-remitting multiple sclerosis, as it is the only FDA and European Medicines Agency approved drug for this condition. Studies and case reports have demonstrated its ability to stabilize the disease and reduce relapse rates in pediatric patients.12345
Is fingolimod safe for use in pediatric multiple sclerosis?
Fingolimod, also known as Gilenya, has been approved for use in children with relapsing multiple sclerosis and has been shown to be generally safe, though it may cause side effects like heart issues, infections, and eye problems. Long-term studies have confirmed its safety profile, but monitoring is recommended, especially after the first dose.12567
How does the drug Ocrelizumab differ from other treatments for pediatric multiple sclerosis?
Ocrelizumab is unique because it targets a specific type of immune cell called B-cells, which are involved in the immune response that damages the nervous system in multiple sclerosis. This is different from other treatments like fingolimod, which works by trapping immune cells in the lymph nodes to prevent them from reaching the brain and spinal cord.12589
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for children and adolescents aged 10 to under 18 with relapsing-remitting multiple sclerosis (RRMS). They must weigh at least 50 kg, have had recent MS activity, and be neurologically stable. It's not for those with other neurological conditions that look like MS, uncontrolled diseases, active infections, or severe heart issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive either ocrelizumab by IV infusion every 24 weeks or fingolimod orally daily, with a placebo of the other treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension (optional)
Participants may opt into continuation of ocrelizumab treatment for at least 144 weeks
Treatment Details
Interventions
- Fingolimod
- Ocrelizumab
Fingolimod is already approved in European Union, United States, Canada for the following indications:
- Relapsing forms of multiple sclerosis
- Relapsing forms of multiple sclerosis
- Relapsing forms of multiple sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University