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Tolebrutinib for Multiple Sclerosis (GEMINI 2 Trial)
GEMINI 2 Trial Summary
This trial is testing a new drug, SAR442168, to see if it is better than the current standard of care, Aubagio, at reducing relapses in people with relapsing forms of MS.
GEMINI 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGEMINI 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.GEMINI 2 Trial Design
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Who is running the clinical trial?
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- I have had at least one relapse or a new lesion on my MRI in the past year.My disability level allows me to walk without aid or rest for 200 meters.I have a history of or am at risk for serious infections.I do not have bleeding disorders, psychiatric issues, or substance abuse problems.You should not donate sperm during the study.I have been diagnosed with RMS based on the latest criteria.I have been diagnosed with progressive multiple sclerosis without relapses.I am a male and agree to not donate sperm and either abstain from sex or use contraception.I am between 18 and 55 years old.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I have taken a pregnancy test recently and it was negative.I have had at least one relapse in the past year or two relapses in the past two years, or an MRI showed at least one active lesion in the past year.My disability level allows me to walk without aid or rest for about 200 meters.I am between 18 and 55 years old.I have been diagnosed with RMS based on the latest criteria.Men or women should use the same contraceptive method as their partner.
- Group 1: SAR442168
- Group 2: Teriflunomide
- 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
In how many different parts of the country is this trial taking place?
"This study is being conducted by 8400088 in Torrance, California, 8400070 in Arcadia, Kentucky, 8400110 in Lexington, Texas, and other research facilities."
Could you detail the Tolebrutinib's safety record?
"Tolebrutinib has received a score of 3 for safety. This is because Tolebrutinib is in Phase 3 trials, which suggests that not only is the medication effective, but that there is also reliable evidence for its safety."
How many people are currently signed up to participate in this research project?
"This study is not recruiting patients at the moment, with the last update on the site being from August 5th, 2022. However, there are 558 other trials for patients with multiple sclerosis and 13 trials for Tolebrutinib."
Who does this trial seek as participants?
"This clinical trial is accepting 900 patients with multiple sclerosis aged 18 and 55. Most importantly, candidates are required to meet the following criteria:The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit.≥1 documented relapse within the previous year OR ≥2 documented relapses within the previous 2 years, OR ≥1 documented"
Does this research include geriatric patients in the experimental group?
"This clinical trial only allows for enrolment from patients that are aged 18 to 55. There are 43 studies available for minors and 405 for elderly patients."
Are there other ongoing experiments that test Tolebrutinib's effects?
"The drug tolebrutinib was first trialled in 2014 at ISN 056001. Up until now, there have been a total of 27 completed clinical trials. Presently, 13 different trials are actively recruiting patients, with a concentration of these studies in Torrance, California."
Are participants still being sought for this research?
"Unfortunately, this specific trial is not looking for new patients at the moment. This is according to the latest update on clinicaltrials.gov, which has the trial listed as last being updated on August 5th, 2022. Although, there are 571 other trials that are currently recruiting."
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