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Evobrutinib vs Teriflunomide for Multiple Sclerosis
Study Summary
This trial will compare the effectiveness of two different drugs for treating relapsing multiple sclerosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with Progressive MS without recent relapses.My disease has lasted more than 10 years and I have mild disability.I have been diagnosed with RMS according to the 2017 McDonald criteria.I do not have an immune disorder requiring steroids, except for well-controlled Type 2 diabetes or thyroid disease.I am a male and will avoid fathering children or use contraception for 2 years after the study.I have had at least one relapse in the past 2 years or a recent MRI showing active disease.I am not pregnant, breastfeeding, and can't get pregnant or I'm using birth control.
- Group 1: Teriflunomide + Evobrutinib matched Placebo: DB Period
- Group 2: Evobrutinib + Teriflunomide matched Placebo: DB Period
- 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
For this particular experiment, are octogenarians able to enroll?
"This clinical study is only open to patients that are between the ages of 18 and 55."
What is the status of Evobrutinib's FDA approval?
"Evobrutinib's safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, so there is both some efficacy data as well as multiple rounds of safety data supporting this estimate."
What other research exists on this topic?
"Work on Evobrutinib began in 2014 with a study sponsored by Genzyme, which is owned by Sanofi. This first Phase 3 trial had 166 participants. As of now, there are 14 active studies being conducted in 62 countries and 323 cities."
Are participants being recruited for this research project currently?
"Unfortunately, this particular clinical trial is no longer admitting patients. The study was first posted on June 12th 2020 but the last update occurred on November 7th, 2022. However, if you are still exploring your options, there are 563 trials for multiple sclerosis and 14 for Evobrutinib that are actively recruiting participants right now."
Could you tell me how many test subjects are involved in this experiment?
"This particular trial is not accepting patients at the moment. It was originally posted on June 12th, 2020 and updated for the last time on November 7th, 2022. There are 563 other trials concerning multiple sclerosis that are currently enrolling patients as well as 14 different clinical trials involving Evobrutinib which are actively recruiting participants."
How many research facilities are coordinating this trial?
"There are 20 medical centres participating in this trial, including locations in Baltimore, Patchogue, and Phoenix."
Is Evobrutinib a new or experimental drug?
"Evobrutinib was first trialled in 2014 at site 056001. As of now, 38 investigations have been completed while 14 are still ongoing. The majority of these studies taking place near Baltimore, Maryland."
What type of patients would be the best match for this clinical trial?
"This study is looking for 898 participants that have been diagnosed with multiple sclerosis. The patients must be aged 18 to 55 and meet the following criteria: -Have had one or more documented relapses in the 2 years before screening OR have at least 1 gadolinium-enhancing T1 lesion within 6 months of randomization -An Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline -For those with an EDSS score <=2, disease duration (time since onset of symptoms) must be no more than 10 years"
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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