Multiple Sclerosis Research Study
Researchers at Tufts Medical Center are evaluating the efficacy, safety, and tolerability of remibrutinib, to support regulatory approval worldwide as a treatment for RMS.
Fast Facts
Ages 18-55
Diagnosed with RRMS OR SPMS
Cost for Transportation and Expenses Covered
Conducted in Boston, MA
Study Background
Researchers at Tufts Medical Center are trying to provide efficacy, safety and tolerability for remibrutinib, to support regulatory approval worldwide as a treatment for RMS.
This study is a randomized, double-blind study comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis. The study is followed by extended treatment with open-label remibrutinib.
Participaints must be diagnosis with RMS according to the 2017 McDonald diagnostic criteria (this would include relapsing-remitting course (RRMS) or secondary progressive (SPMS) course with disease activity) as confirmed at screening visit.
Study Background
Researchers at Tufts Medical Center are trying to provide efficacy, safety and tolerability for remibrutinib, to support regulatory approval worldwide as a treatment for RMS.
This study is a randomized, double-blind study comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis. The study is followed by extended treatment with open-label remibrutinib.
Participaints must be diagnosis with RMS according to the 2017 McDonald diagnostic criteria (this would include relapsing-remitting course (RRMS) or secondary progressive (SPMS) course with disease activity) as confirmed at screening visit.
Additional Information
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Male or female participants 18 to 55 years of age at time of screening
- Diagnosis of RMS according to the 2017 McDonald diagnostic criteria (this would include relapsing-remitting course (RRMS) or secondary progressive (SPMS) course with disease activity) as confirmed at the screening visit.
- At least: 1 documented relapse within the previous year, OR 2 documented relapses within the previous 2 years, prior to screening, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months prior to screening.
Exclusion Criteria
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revisions of the McDonald diagnostic criteria at screening.
- Disease duration of more than 10 years in participants with an EDSS score of 2 or less at screening
- History of clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders that may mimic MS at screening.
Enrolling in this study involves an initial screening visit.
After screening, there is the treatment phase that occurs at Month 1 (after screening), M3, M6, M9, and every 3 months until M30/end of study visits.
All visits are conducted in person at Tufts Medical Center. Visits will include the collection of blood and urine samples, MS-related assessments, MRIs, and study drug dispensation.
Participants will not be paid for study participation but will be reimbursed to cover the costs of travel and expenses when attending study visits.
There is no cost for you to participate in our research study.