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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 8 years
Awards & highlights

Operetta 2 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.Check my eligibility
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.See study design
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.

Operetta 2 Trial 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.

Operetta 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized relapse rate (ARR)
Secondary outcome measures
Annualized relapse rate (ARR) by Week 96
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Number of T1 Gd lesions at Week 12
+3 more

Operetta 2 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 3
~5730

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,835 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,796 Patients Enrolled for Multiple Sclerosis
PPDIndustry Sponsor
159 Previous Clinical Trials
36,694 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
220 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,707 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,123 Patients Enrolled for Multiple Sclerosis

Media Library

Fingolimod (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05123703 — Phase 3
Multiple Sclerosis Research Study Groups: Ocrelizumab, Fingolimod
Multiple Sclerosis Clinical Trial 2023: Fingolimod Highlights & Side Effects. Trial Name: NCT05123703 — Phase 3
Fingolimod (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123703 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project only enrolling adults who are 20 or older?

"This trial is currently enrolling patients that are between 10 to 17 years old."

Answered by AI

How can I sign up to participate in this research?

"This study will be enrolling 233 adolescent patients that suffer from multiple sclerosis. In order to qualify, these individuals must also weigh more than 50 kg, have had no changes in their condition for the last 30 days, and remain stable between screening and Day 1 of the trial."

Answered by AI

Is this the first study of its kind?

"Ocrelizumab has been under investigation for over a decade at this point. The first official clinical trial was sponsored by Genentech, Inc in 2008 and involved 220 patients. After the success of this initial study, Ocrelizumab received Phase 2 drug approval in 2008 as well. Presently, there are 36 active trials being conducted with Ocrelizumab across 63 countries and 361 cities."

Answered by AI

To what ailments is Ocrelizumab most often prescribed?

"Ocrelizumab is an effective alternative treatment for patients with carcinoma in situ and active secondary progressive multiple sclerosis (spms)."

Answered by AI

How many different hospitals are a part of this clinical trial?

"To make the study as accessible as possible, it is being run out of 21 locations which include Cleveland, La Jolla and New york. You will be asked to select the clinic nearest you when enrolling to minimize travel time and disruption."

Answered by AI

How many test subjects are involved in this experiment?

"That is correct. The publicly available information on clinicaltrials.gov says that this study, which was first advertised on February 4th, is still looking for 233 individuals to be spread out across 21 different sites."

Answered by AI

Is this the first time that Ocrelizumab has been tested in a clinical setting?

"Ocrelizumab was first studied in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge. Since then there have been 56 completed studies. There are presently 36 live clinical trials, with a significant number of these trials based in Cleveland, Ohio."

Answered by AI

Is there still room for people to participate in this experiment?

"The listed clinical trial on clinicaltrials.gov is still recruiting patients, with the most recent update having been on October 17th, 2022. The study was initially posted February 4th of the same year."

Answered by AI

Has Ocrelizumab received approval from the Federal Drug Administration?

"Ocrelizumab has undergone Phase 3 clinical trials, meaning that there is data supporting both its efficacy and safety. Thus, our team rates it as a 3 on our scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
2022. "A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123703.
~80 spots leftby Jul 2025
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