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Fenebrutinib vs Ocrelizumab for Multiple Sclerosis (FENtrepid Trial)
FENtrepid Trial Summary
This trial will evaluate if fenebrutinib can help slow down disability progression in adults with PPMS, compared to placebo or to the standard of care drug ocrelizumab.
FENtrepid Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFENtrepid Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FENtrepid Trial Design
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Who is running the clinical trial?
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- I can walk 25 feet in less than 150 seconds.I am a man and plan to try for a child during the study or within 28 days after the last dose.I do not have any major health issues that could affect the study.I do not have any active infections, including Hepatitis B or C, TB, or PML.I have cirrhosis but can still perform daily activities.I haven't had cancer, except for certain skin cancers or cervical cancer treated over a year ago.My neurological condition has been stable for the last 30 days.I am between 46 and 65 years old and live in Germany or Italy.My disability level is moderate to severe but I can still walk.I haven't taken any immune-altering drugs recently without a break.I have a weakened immune system or have had an organ transplant.I am not pregnant, breastfeeding, nor planning to become pregnant during the study or up to 12 months after.I have not received a live vaccine in the last 6 weeks.I can complete a hand dexterity test in less than 4 minutes.I am on a stable dose of medication for my condition and plan to keep it the same during the study.My condition is diagnosed as PPMS according to the 2017 criteria.I agree to not have sex or use birth control and not donate sperm.I have had a severe reaction to an infusion or to ocrelizumab.I am not on long-term steroids, immunosuppressants, or other drugs that could affect the study.I do not have good veins for IV access.I have a bleeding disorder, anemia, or a history of serious GI bleeding.I have previously been treated with specific immunosuppressive drugs.My disability has worsened in the last year.
- Group 1: Fenebrutinib
- Group 2: Ocrelizumab
- 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
Are we still able to enroll new participants in this research project?
"Yes, this information is accurate according to the clinicaltrials.gov website. The study was first posted on October 26th, 2020 and was last edited October 27th, 2020."
Who meets the requirements to join this clinical trial?
"Eligible patients for this particular study must have primary progressive multiple sclerosis and should be between 18-65 years old. The researchers conducting the trial are looking to enroll around 946 individuals."
Are there any participating hospitals in North America for this clinical trial?
"This trial has many available locations, some of which include St. Michael's Hospital; MS Clinic in Toronto, Alabama Neurology Associates in Homewood, and University of Rochester in Rochester. In total, there are 49 sites where this trial is offered."
Are there any antecedent studies to fenebrutinib?
"Fenebrutinib was first researched in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge. 2705 studies have been completed thus far, with 32 ongoing trials. A fair number of these active studies are based in Toronto, Ontario."
For this particular experiment, are elderly individuals being recruited as participants?
"This study is enrolling participants who are of legal age and younger than 65 years old."
What are the possible harmful side effects of fenebrutinib?
"Fenebrutinib's safety is well-documented, as this drug has reached Phase 3 clinical trials. This gives it a score of three on our Power team's scale."
Have these treatments been tested before in humans?
"Fenebrutinib has been under investigation for over a decade with the first clinical trial starting in 2008. This initial study, which had 220 participants, was conducted by Genentech, Inc.. After this Phase 2 drug approval occurred in 2008, there are now 32 active trials being conducted across 337 cities and 65 countries."
How many people fit the screening criteria for this research project?
"946 individuals that meet the clinical study's entrance requirements are needed to complete the trial. The sponsor, Hoffmann-La Roche, will be managing the research from multiple locations including St. Michael's Hospital; MS Clinic in Toronto, Ontario and Alabama Neurology Associates in Homewood, Alabama."
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