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Ocrelizumab vs Fingolimod for Pediatric Multiple Sclerosis (Operetta 2 Trial)
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.
Operetta 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOperetta 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Operetta 2 Trial Design
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Who is running the clinical trial?
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- My disability level allows me to walk without aid or rest for at least 200 meters.I have been diagnosed with RRMS according to recognized medical standards.I might have or am suspected to have a neurological condition similar to MS.My neurological condition has been stable for over a month.My body weight is 50 kg or more.I do not have any severe illnesses or infections that would stop me from joining the study.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.I have severe heart problems or abnormal heart test results.
- Group 1: Ocrelizumab
- Group 2: Fingolimod
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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)."
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."
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."
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."
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."
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."
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