BIP_Johns Hopkins TREAT-MS
TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability.
The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an 'early aggressive' therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.
Key Inclusion Criteria:
-Aged 18-60 years and meet the 2017 McDonald criteria for relapsing-remitting MS.
-Must be EITHER John Cunningham (JC) virus antibody negative or low positive (index antibody titer <0.9), OR negative for: Hepatitis B and C, tuberculosis.
Key Exclusion Criteria:
-Prior treatment with rituximab, ocrelizumab, alemtuzumab, mitoxantrone or cladribine.
-Prior treatment with any other MS DMT for more than 6 months.
-Prior treatment with experimental aggressive therapies (e.g., T-cell vaccine, total lymphoid radiation, stem cells).
-Treatment with teriflunomide within past 2 years (even for ≤ 6 months), unless rapid wash out done (i.e., with cholestyramine or activated charcoal).
-Treatment in the past 6 months with any MS DMT.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Elisabeth Lucassen, M.D.
PCORI (Patient-Centered Outcomes Research Institute)
- Providence St. Vincent Medical Center