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Bruton's Tyrosine Kinase (BTK) Inhibitor
Remibrutinib vs Teriflunomide for Multiple Sclerosis
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
EDSS score of 0 to 5.5 (inclusive)
18 to 55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 month
Awards & highlights
Study Summary
This trial compares the two drugs remibrutinib and teriflunomide to see which is better at treating relapsing multiple sclerosis, and if either drug has any serious side effects.
Who is the study for?
Adults aged 18-55 with Relapsing Multiple Sclerosis (RMS) as per the McDonald criteria, an EDSS score of 0 to 5.5, and a recent history of relapses or active lesions are eligible. Exclusions include those with certain cancers, mental health risks, other immune diseases besides MS, substance abuse issues, significant organ disorders or infections, severe allergies to study drugs or components, pregnant/nursing women, and those not using effective contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Remibrutinib compared to Teriflunomide in treating RMS. Participants will be randomly assigned to receive either Remibrutinib or Teriflunomide while their health outcomes are monitored.See study design
What are the potential side effects?
Potential side effects for both medications may include liver problems, hair thinning or loss (Teriflunomide), increased risk of infection due to immune system effects (Remibrutinib), gastrointestinal disturbances like nausea or diarrhea, headaches and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disability level allows me to walk without aid or rest for at least 200 meters.
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I am between 18 and 55 years old.
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My condition meets the 2017 criteria for RMS diagnosis.
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My neurological condition has been stable for the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 30 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 month
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) of confirmed relapses [Core Part]
Secondary outcome measures
Annualized rate of new or enlarging T2 lesion [Core Part]
Annualized rate of new or enlarging T2 lesion [Extension Part]
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
+30 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Remibrutinib - Extension (on teriflunomide in Core)Experimental Treatment1 Intervention
Participants on teriflunomide in Core will switch to remibrutinib tablet
Group II: Remibrutinib - ExtensionExperimental Treatment1 Intervention
Participants on remibrutinib in Core will continue on remibrutinib tablet
Group III: Remibrutinib - CoreExperimental Treatment1 Intervention
Remibrutinib tablet and matching placebo of teriflunomide capsule
Group IV: Teriflunomide - CoreActive Control1 Intervention
Teriflunomide capsule and matching placebo remibrutinib tablet
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,197,444 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
51,327 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk for hepatitis reactivation.I have had my spleen removed.My condition has worsened at least once in the past year or I have had a new active lesion.My disease has lasted over 10 years and I have little to no disability.I have severe kidney problems or high creatinine levels.My disability level allows me to walk without aid or rest for at least 200 meters.I have a chronic immune system disease other than MS, but it's under control.I have a significant brain or nerve condition other than multiple sclerosis.I have had Progressive Multifocal Leukoencephalopathy or symptoms like it.I have been diagnosed with primary progressive multiple sclerosis.I do not have any major health issues that could affect the study.I have no history or current treatment for serious liver diseases.I am between 18 and 55 years old.My condition meets the 2017 criteria for RMS diagnosis.I do not have any serious ongoing infections.My neurological condition has been stable for the last month.I have a condition like asthma or IBD that often requires steroids.I have had cancer before, but it was completely removed or was only skin or cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Remibrutinib - Core
- Group 2: Teriflunomide - Core
- Group 3: Remibrutinib - Extension
- Group 4: Remibrutinib - Extension (on teriflunomide in Core)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what type of patient does this research pertain?
"This study is for individuals with sclerosis who are between 18-55 years old. There are approximately 800 slots available for participants."
Answered by AI
Are octogenarians able to participate in this research?
"Eligibility for this study is limited to individuals aged 18-55. There are currently 44 trials in progress for patients that are minors and 406 studies underway for elderly adults."
Answered by AI
Can more people sign up to participate in this trial?
"That is correct, the website clinicaltrials.gov has information indicating that this study is looking for patients as we speak. The posting date was December 16th 2021 and the most recent update was November 11th 2022. In total, 23 sites are recruiting 800 individuals for this trial."
Answered by AI
What other medical studies have included Remibrutinib as a treatment?
"Remibrutinib was first looked into back in 2014 at site 056001. So far, there have been a total of 27 studies completed with 13 more ongoing clinical trials. A large majority of these investigations are taking place near Saint Petersburg, Florida."
Answered by AI
What is the latest information on Remibrutinib's FDA approval status?
"Remibrutinib's safety is estimated to be a 3. This is based on the fact that remibrutinib is in Phase 3 trials, which means there is not only some data supporting efficacy, but also multiple rounds of data supporting safety."
Answered by AI
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