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Immunomodulator

Ocrelizumab vs Fingolimod for Pediatric Multiple Sclerosis (Operetta 2 Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

EDSS at screening: 0-5.5, inclusive

Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017

Must not have

Known presence or suspicion of other neurologic disorders that may mimic MS

Patient with severe cardiac disease or significant findings on the screening ECG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will compare the safety and efficacy of two drugs for treating multiple sclerosis in children and adolescents aged 10-18.

Who is the study for?

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.

What is being tested?

The study compares the safety and effectiveness of two drugs: Ocrelizumab and Fingolimod. Participants will receive either one of these drugs or a placebo without knowing which one they are getting. The trial will last at least 96 weeks.

What are the potential side effects?

Ocrelizumab may cause infusion reactions, infections due to weakened immune response, skin changes, and potential risk of malignancies. Fingolimod can lead to slow heart rate upon first dose, vision problems, headache, liver issues and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disability level allows me to walk without aid or rest for at least 200 meters.

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I have been diagnosed with RRMS according to recognized medical standards.

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My neurological condition has been stable for over a month.

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My body weight is 50 kg or more.

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I have had at least one MS flare-up in the last year or two in the last two years, or an MRI showed active MS lesions recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might have or am suspected to have a neurological condition similar to MS.

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I have severe heart problems or abnormal heart test results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OcrelizumabExperimental Treatment2 Interventions

Participants will receive Ocrelizumab by IV infusion every 24 weeks. The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15 and subsequent doses are given as single infusions of ocrelizumab every 24 weeks. Participants will also receive a placebo of fingolimod (administered as QD capsule).

Group II: FingolimodActive Control2 Interventions

Participants will receive Fingolimod PO QD as per the prescribing information provided with fingolimod. Patients will also receive a placebo of ocrelizumab (administered as IV infusions on Days 1 and 15, and every 24 weeks thereafter).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~8600

0 / 7Eligibility criteria met