Condition: Multiple sclerosis
Key Inclusion Criteria
- 18-60 years old
- Meets criteria for relapsing-remitting multiple sclerosis
- Must be either JC virus antibody-negative or low positive OR negative for hepatitis B and C and tuberculosis
Key Exclusion Criteria
- Prior treatment with rituximab, ocrelizumab, alemtuzumab, mitoxantrone or cladribine
- Prior treatment with any other disease-modifying therapy for multiple sclerosis for more than 6 months
- Prior treatment with experimental aggressive therapies
Full Study Name
Traditional Versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial (IRB no. 52894)
The purpose of this study is to identify the most appropriate treatment strategy for individuals with multiple sclerosis (MS), especially shortly after diagnosis when it may be most possible to increase a patient’s chance for preventing longer-term disability. Researchers aim to determine whether patients would most benefit from an earlier, aggressive therapy, or whether a traditional therapy, followed by a switch if relapses or new MRI lesions occur, is the best approach to preventing long-term disability. The study will capture patient-reported outcomes to shed light on treatment strategies that may be best from a patient-centered perspective.
After eligibility for the study has been established, the participant’s specific features of disease activity will be evaluated, and a classification will be made, based on whether two or more features of MS are present that indicate a greater likelihood of longer-term disability. The patient will then be placed into a study group that receives traditional therapy or a group that receives early, aggressive therapy.